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Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia

NCT02332577 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2023-05-08

No results posted yet for this study

Summary

Primary Objective:

To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment.

Secondary Objectives:

To evaluate the clinical efficacy in a subpopulation bacteriologically documented at inclusion and according to procalcitonin level.

To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse and mortality 30±2 days after treatment is started.

To document failures. To collect and follow up adverse events.

Conditions

Interventions

DRUG

PRISTINAMYCIN XRP7263

Pharmaceutical form:tablet 500 mg Route of administration: oral

DRUG

Amoxicillin

Pharmaceutical form:capsule 500 mg Route of administration: oral

DRUG

Amoxicillin Placebo

Pharmaceutical form: capsule Route of administration: oral

DRUG

PRISTINAMYCIN Placebo

Pharmaceutical form:Tablet Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2023-02-20
Completion
2023-02-20

Countries

  • France
  • Tunisia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02332577 on ClinicalTrials.gov