Clinical Trial Results:
Use of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia : a multicenter, parallel-group, open-label, randomized controlled trial
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Summary
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EudraCT number |
2020-001324-33 |
Trial protocol |
FR |
Global end of trial date |
14 Apr 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jun 2022
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First version publication date |
26 Jun 2022
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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 |
APHP200392
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04334850 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
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Sponsor organisation address |
4 Avenue Victoria, Paris, France, 75004
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Public contact |
Hôpital Tenon, AP-HP, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, +33 1 56 01 65 74, muriel.fartoukh@aphp.fr
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Scientific contact |
Hôpital Tenon, AP-HP, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, +33 1 56 01 65 74, muriel.fartoukh@aphp.fr
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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 |
14 Jan 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Apr 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Apr 2021
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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 |
To assess the efficacy of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin, on antibiotics exposure, as compared with a conventional strategy, in severe confirmed COVID-19 pneumonia.
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Protection of trial subjects |
Patients benefit from specific medical monitoring.
AP-HP has taken all measures to conduct this research in accordance with the provisions of the Public Health Code applicable to research involving humans.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Apr 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
France: 194
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Worldwide total number of subjects |
194
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EEA total number of subjects |
194
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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) |
83
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From 65 to 84 years |
109
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85 years and over |
2
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Recruitment
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Recruitment details |
Participants to be recruited among adults with COVID-19 pneumonia admitted to the IC. | |||||||||
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Pre-assignment
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Screening details |
Participants to be recruited among adults with COVID-19 pneumonia admitted to the IC, the screening is done according to the recruiting criterias. | |||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
NA
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Conventional strategy | |||||||||
Arm description |
Conventional strategy, in severe confirmed COVID-19 pneumonia. | |||||||||
Arm type |
Control arm | |||||||||
Investigational medicinal product name |
antibiotics
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for injection, Cachet
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Routes of administration |
Buccal use, Intravenous use
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Dosage and administration details |
Conventional dosage
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Arm title
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mPCR FA-PPP and PCT | |||||||||
Arm description |
A strategy combining a mPCR FA-PPP and an algorithm of early antibiotics adaptation and discontinuation based on both the mPCR FA-PPP results and the PCT. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
antibiotics
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cachet, Solution for injection/infusion
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Routes of administration |
Buccal use, Intracavernous use
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Dosage and administration details |
Adminisatration via intravenous or bucal.
Dosage will be patient depdendant.
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Baseline characteristics reporting groups
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Reporting group title |
Conventional strategy
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Reporting group description |
Conventional strategy, in severe confirmed COVID-19 pneumonia. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
mPCR FA-PPP and PCT
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Reporting group description |
A strategy combining a mPCR FA-PPP and an algorithm of early antibiotics adaptation and discontinuation based on both the mPCR FA-PPP results and the PCT. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Conventional strategy
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Reporting group description |
Conventional strategy, in severe confirmed COVID-19 pneumonia. | ||
Reporting group title |
mPCR FA-PPP and PCT
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Reporting group description |
A strategy combining a mPCR FA-PPP and an algorithm of early antibiotics adaptation and discontinuation based on both the mPCR FA-PPP results and the PCT. | ||
Subject analysis set title |
Primary : Number of antibiotic free days at D28
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The primary assessment criterion is the number of antibiotic free days at D28, which corresponds to the number of days alive without any antibiotics at Day 28.
The D28 time point is usual in studies assessing antibiotic use in ICU patients.
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End point title |
Primary : Number of antibiotic free days at D28 | |||||||||
End point description |
The primary assessment criterion is the number of antibiotic free days at D28, which corresponds to the number of days alive without any antibiotics at Day 28.
The D28 time point is usual in studies assessing antibiotic use in ICU patients.
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End point type |
Primary
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End point timeframe |
3 months
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Statistical analysis title |
Primary : Number of antibiotic free days at D28 | |||||||||
Comparison groups |
Conventional strategy v mPCR FA-PPP and PCT
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Number of subjects included in analysis |
191
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.895 | |||||||||
Method |
negative binomial distributions | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
3 months
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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 |
24
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Unfortunately AE list with SOC are not available yet. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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01 Sep 2020 |
- Prolongation de la durée des inclusions de 6 mois, afin de pouvoir compléter
les objectifs d’inclusion en cas de deuxième vague de l’épidémie ;
- Changement d’Investigateurs dans deux centres participant. |
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06 Apr 2021 |
- Changement d’Investigateurs dans deux centres participant. |
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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 | |||
