Clinical Trial Results:
An Open Label, Non-Comparative Study To Evaluate Parasitological Clearance Rates And Pharmacokinetics Of Azithromycin And Chloroquine Following Administration Of A Fixed Dose Combination Of Azithromycin And Chloroquine (AZCQ) In Asymptomatic Pregnant Women With Plasmodium Falciparum Parasitemia In Sub-Saharan Africa.
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Summary
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EudraCT number |
2014-004906-14 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
25 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
25 May 2016
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First version publication date |
31 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A0661201
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01103713 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Aug 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Oct 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective was to evaluate the peripheral parasitological clearance rate of Azithromycin/chloroquine (AZCQ) on Day 28 (Polymerase chain-reaction [PCR] corrected) following first dose of 3-day dosing regimen of AZCQ in asymptomatic pregnant women with P. falciparum parasitemia.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Mar 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Benin: 1
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Country: Number of subjects enrolled |
Kenya: 67
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Country: Number of subjects enrolled |
Malawi: 50
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Country: Number of subjects enrolled |
Tanzania, United Republic of: 1
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Country: Number of subjects enrolled |
Uganda: 49
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Worldwide total number of subjects |
168
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
41
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Adults (18-64 years) |
127
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled at 5 active sites in 5 countries: Benin (site 1012), Kenya (site 1004), Malawi (site 1015), Tanzania (site 1008), and Uganda (site 1013). The enrollment of the first subject took place on 07 March 2011 and the last subject last visit was on 25 October 2013. | ||||||||||||||||
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Pre-assignment
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Screening details |
A total of 404 subjects were screened and 168 subjects were assigned to study drug, enrolled and treated. Of the 168 subjects, two subjects were excluded from the pharmacokinetic (PK) analysis, modified intent-to-treat (MITT), intent-to-treat (ITT) and per protocol (PP) populations due to informed consent protocol deviations. | ||||||||||||||||
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Period 1
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Period 1 title |
overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Azithromycin (AZ)/Chloroquine (CQ) | ||||||||||||||||
Arm description |
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ given orally once daily for 3 days (Days 0, 1, 2). | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
AZCQ fixed dose combination tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 milligram (mg) AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
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Baseline characteristics reporting groups
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Reporting group title |
Azithromycin (AZ)/Chloroquine (CQ)
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Reporting group description |
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ given orally once daily for 3 days (Days 0, 1, 2). | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Azithromycin (AZ)/Chloroquine (CQ)
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Reporting group description |
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ given orally once daily for 3 days (Days 0, 1, 2). | ||
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End point title |
Percentage of Subjects With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication [1] | ||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A subject will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. Modified Intent To Treat (MITT) population was used. MITT is a subset of the Intent To Treat (ITT) population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Primary
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End point timeframe |
Day 28
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication [2] | ||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A subjects will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. Per Protocol (PP) population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Primary
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End point timeframe |
Day 28
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A subjects will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percentage of Subjects With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | ||||||||||||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A subjects will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percentage of Subjects With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A subject will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. ITT population was used. ITT is defined as all subjects who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Subjects With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A subject will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure. MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Subjects With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A subject will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure. PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Subjects With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||||
End point description |
The proportion of subjects with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A subject will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure. ITT population was used. ITT is defined as all subjects who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Number of Asexual P. Falciparum per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||||
End point description |
Parasite counts (actual counts per microliter of blood) was measured at various time points. ITT population was used. ITT is defined as all subjects who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Number of Asexual P. Falciparum per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||||
End point description |
Parasite counts (actual counts per microliter of blood) was measured at various time points. MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Number of Asexual P. Falciparum per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | ||||||||||||||||||||
End point description |
Parasite counts (actual counts per microliter of blood) was measured at various time points. PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Secondary
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End point timeframe |
Days 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Summary of Pregnancy Outcome: Location of Delivery | ||||||||||||||
End point description |
All subjects were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy. The safety analysis set consists of subjects who received at least one dose of study medication. Data was available for 160 subjects only.
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End point type |
Other pre-specified
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End point timeframe |
Following delivery or pregnancy termination
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Summary of Pregnancy Outcome: Mode of Delivery | ||||||||||||
End point description |
All subjects were followed up for EIU safety assessments following delivery or termination of pregnancy. The safety analysis set consists of subjects who received at least one dose of study medication. Data was available for 160 subjects only.
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End point type |
Other pre-specified
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End point timeframe |
Following delivery or pregnancy termination
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel? | ||||||||||||
End point description |
All subjects were followed up for EIU safety assessments following delivery or termination of pregnancy. The safety analysis set consists of subjects who received at least one dose of study medication. Data was available for 159 subjects only.
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End point type |
Other pre-specified
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End point timeframe |
Following delivery or pregnancy termination
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Summary of Pregnancy Outcome: Labor Induced? | ||||||||||||
End point description |
All subjects were followed up for EIU safety assessments following delivery or termination of pregnancy. The safety analysis set consists of subjects who received at least one dose of study medication. Data was available for 158 subjects only.
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End point type |
Other pre-specified
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End point timeframe |
Following delivery or pregnancy termination
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Summary of Pregnancy Outcome: Complications During Delivery? | ||||||||||||
End point description |
All subjects were followed up for EIU safety assessments following delivery or termination of pregnancy. The safety analysis set consists of subjects who received at least one dose of study medication. Data was available for 159 subjects only.
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End point type |
Other pre-specified
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End point timeframe |
Following delivery or pregnancy termination
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Summary of Pregnancy Outcome: Outcome of Birth | ||||||||||||||||||
End point description |
All subjects were followed up for EIU safety assessments following delivery or termination of pregnancy. The safety analysis set consists of subjects who received at least one dose of study medication. Data was available for 160 subjects only.
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End point type |
Other pre-specified
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End point timeframe |
Following delivery or pregnancy termination
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Incidence of Fever Based on Oral Temperature | ||||||||||||||||||||||||||
End point description |
Oral temp was taken by the fieldworker through Day 42. ITT is defined as all subjects who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two subjects were excluded because they had protocol deviations regarding the informed consent process.
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End point type |
Other pre-specified
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End point timeframe |
Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level | ||||||||
End point description |
Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value <0.8 times lower limit of normal was considered clinically significant. The safety analysis set consists of subjects who received at least one dose of study medication.
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End point type |
Other pre-specified
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End point timeframe |
Day 42
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| No statistical analyses for this end point | |||||||||
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End point title |
Summary of Serum Azithromycin Concentration Versus Time | ||||||||||||||||||||
End point description |
AZ concentrations in the serum was determined at specified time points as PK endpoints. Analyses population included all subjects who received at least one dose of study medication and had at least one blood sample collected for PK analysis. Here, "99999" in the arithmetic mean and standard deviation signifies data is not estimable (NA) as the summary statistics has been calculated by setting concentration values below the lower limit of quantification to zero.
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End point type |
Other pre-specified
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End point timeframe |
Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming "hour not specified" as 0 hours on Day 7 and Day 14 for planned time post first dose calculation.
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Summary of Plasma Chloroquine Concentration Versus Time | ||||||||||||||||||||||||
End point description |
CQ concentrations in the plasma were determined at specified time points as PK endpoints. Analyses population included all subjects who received at least one dose of study medication and had at least one blood sample collected for PK analysis. Here, "99999" in the arithmetic mean and standard deviation signifies data is not estimable (NA) as the summary statistics has been calculated by setting concentration values below the lower limit of quantification to zero.
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End point type |
Other pre-specified
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End point timeframe |
Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Summary of Plasma Desethylchloroquine Concentration Versus Time | ||||||||||||||||||||||||
End point description |
CQ concentrations in the plasma were determined at specified time points as PK endpoints. Analyses population included all subjects who received at least one dose of study medication and had at least one blood sample collected for PK analysis. Here, "99999" in the arithmetic mean and standard deviation signifies data is not estimable (NA) as the summary statistics has been calculated by setting concentration values below the lower limit of quantification to zero.
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End point type |
Other pre-specified
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End point timeframe |
Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
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Adverse event reporting additional description |
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Azithromycin/Chloroquine (Familial Status = Neonate)
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Reporting group description |
AZCQ (Familial Status = Neonate). Number of deaths due to adverse events = 4. Number of deaths related to treatment = 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Azithromycin/Chloroquine (Familial Status = Mother)
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Reporting group description |
ACZQ (Familial Status = Mother) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
