NCT00393744 (PRI-angine) is a Phase 3 clinical trial of pristinamycin in Tonsillitis, sponsored by Sanofi.

Who is sponsoring NCT00393744?

NCT00393744 is sponsored by Sanofi.

What drugs are being tested in NCT00393744?

Interventions in NCT00393744: pristinamycin, amoxicillin.

What condition does NCT00393744 study?

NCT00393744 studies Tonsillitis.

Is NCT00393744 still recruiting?

NCT00393744 is currently completed. Last updated 16 March 2009.

Last reviewed 2009-03-16 · How we verify

NCT00393744: PRI-angine

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years.

Completed Phase 3 Last updated 16 March 2009

What this trial tests

Phase 3 trial testing pristinamycin in Tonsillitis in 395 participants. Completed.

Timeline

1 October 2006

Primary endpoint
1 March 2008

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	395
Start date	1 October 2006
Primary completion	1 March 2008
Sites	1 location across France

Drugs / interventions tested

pristinamycin — full drug profile →
amoxicillin (amoxicillin) — full drug profile →

Conditions studied

Tonsillitis — all drugs for Tonsillitis →

Sponsor

Sanofi — full company profile →

Who can join

Adults 6 to 25, any sex, with Tonsillitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

bacterial eradication
Time frame: at V3

Sponsor's own description

The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Different antibiotic treatments for group A streptococcal pharyngitis.
van Driel ML, De Sutter AI, Habraken H, Thorning S, et al · · 2016 · cited 33× · PMID 27614728 · DOI 10.1002/14651858.cd004406.pub4
Different antibiotic treatments for group A streptococcal pharyngitis.
van Driel ML, De Sutter AI, Thorning S, Christiaens T. · · 2021 · cited 15× · PMID 33728634 · DOI 10.1002/14651858.cd004406.pub5
Different antibiotic treatments for group A streptococcal pharyngitis.
Hedin K, Thorning S, van Driel ML. · · 2023 · cited 2× · PMID 37965935 · DOI 10.1002/14651858.cd004406.pub6

Verify or expand the search:

Other recruiting trials for Tonsillitis

Currently open trials in the same condition.

NCT06576830 — Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia · Phase 4 · recruiting
NCT06326983 — Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery · NA · recruiting
NCT05656365 — Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA · recruiting
NCT03654742 — Intracapsular Tonsillectomy in Adults · NA · active not recruiting
NCT03625011 — Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy · Phase 4 · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00393744 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 16 March 2009

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00393744.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing