Clinical Trial Results:
Evaluation of the potential anti-malarial effect of ivermectin: a controlled human malaria infection trial
Summary
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EudraCT number |
2017-002723-16 |
Trial protocol |
DE |
Global end of trial date |
12 Dec 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Sep 2022
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First version publication date |
02 Sep 2022
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Other versions |
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Summary report(s) |
Publication on a medical journal |
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 |
PREMIVER
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Universitaetsklinikum Tuebingen
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Sponsor organisation address |
Geissweg 3 , Tübingen, Germany, 72076
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Public contact |
Institut fuer Tropenmedizin, Universitaetsklinikum Tuebingen, peter.kremsner@uni-tuebingen.de
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Scientific contact |
Institut fuer Tropenmedizin, Universitaetsklinikum Tuebingen, peter.kremsner@uni-tuebingen.de
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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 |
31 Jul 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Dec 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary Objective: To assess whether ivermectin can inhibit the hepatic invasion and development of Plasmodium falciparum and provide partial malarial prophylaxis.
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Protection of trial subjects |
This study was conducted in compliance with the protocol and with the international and national laws and regulations in effect, and in accordance with the applicable directives in particular concerning the submission to the IEC and the protection of personal data. The subject’s informed consent was obtained according to the ethical principles stated in the Declaration of Helsinki 2000 version (amended in Tokyo 2004; Ethical Principles for Medical Research Involving Human Subjects.), the applicable guidelines for the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) (CPMP/ICH/135/95), and the applicable local laws and regulations. The investigator agreed, upon signing the protocol, to adhere to the instructions and procedures described within and to the principles of GCP to which it conforms. The study was monitored in accordance with ICH E6.
Permission to perform the study was obtained in accordance with all applicable regulatory requirements. All ethical and regulatory approvals were available before any subject was exposed to any study-related procedure.
Investigations related to the study were performed by scientifically and medically qualified persons, where the benefits of the study were assessed in proportion to the risks posed by participation.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 May 2018
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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 |
Germany: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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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) |
0
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Adults (18-64 years) |
12
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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 |
- | |||||||||
Pre-assignment
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Screening details |
21 subject were screened, 13 were eligible, 12 were enrolled one was kept as backup. The screenings were performed from 7th to 17th May 2018 | |||||||||
Period 1
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Period 1 title |
Recruitment (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Verum | |||||||||
Arm description |
Ivermectin 400mcg/kg one time | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Ivermectin
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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 |
0.4 mg/kg weight was given with waten unter fasting conditions.
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Arm title
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Placebo | |||||||||
Arm description |
Placebo were tablets containing lactose | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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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 |
To secure the blinding the subjects were given the amount of tablets that they would have gotten, if they would have been in the IMP group (0.4 mg/kg, one IMP tablet contains 3 mg IMP).
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Baseline characteristics reporting groups
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Reporting group title |
Recruitment
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects that followed the clinical trial as requested per protocol
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End points reporting groups
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Reporting group title |
Verum
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Reporting group description |
Ivermectin 400mcg/kg one time | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo were tablets containing lactose | ||
Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects that followed the clinical trial as requested per protocol
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End point title |
Time to microscopically detectable parasitaemia | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The parasitaemia was measured from day 6 on after controlled human malaria infection until positivity or treatment on day 21 twice daily.
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Statistical analysis title |
primary endpoint | ||||||||||||
Comparison groups |
Verum v Placebo
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Number of subjects included in analysis |
12
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
≤ 0.5 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [1] - The primary endpoint of successful malarial infection was assessed for each patient and the number and percent of patients achieving this endpoint summarised for each group. |
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End point title |
Median parasite density at day 12 | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
On day 12
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No statistical analyses for this end point |
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End point title |
Median parasite density at day of treatment | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
time of treatment
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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 |
AEs were collided from signature of the informed consent form until end of follow-up on day 90.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
preferred term | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Verum
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Reporting group description |
Ivermectin 400mcg/kg one time | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo were tablets containing lactose | |||||||||||||||||||||||||||||||||||||||||||||
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/31808594 |