Short Duration Treatment of Non-severe Community Acquired Pneumonia

Community Acquired Pneumonia Clinical Trial

— PTC  

Official title:

A Non-Inferiority, Multicentered, Controlled, Randomized, Double Blinded Study Investigating the Antibiotic Treatment Duration (3-day Versus 8-day) for Subjects Admitted to Emergency Services With Acute Non-severe Community Acquired Pneumonia (CAP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01963442
• Other study ID #: PHRC-12-202.0496 - PTC
• Secondary ID: 2013-000265-36
• Status: Recruiting
• Phase: Phase 2
• First received: October 9, 2013
• Last updated: August 11, 2017
• Start date: November 2013
• Est. completion date: June 2018

Study information

• Verified date: August 2017
• Source: Versailles Hospital
• Contact: Anne-Claude CREMIEUX, PH
• Phone: 0033147107730
• Email: anne-claude.cremieux[@]rpc.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must be 18 years old or over.

• admitted three days before for Community Acquired Pneumonia (CAP) defined by at least one clinical sign of pneumonia (dyspnea, cough, mucopurulent sputum, crackling sound on lungs) associated with a temperature >38°C on admission, and a new infiltrate consistent with pneumonia on chest x-ray, who responded favorably to 3 days of treatment with ß-lactams (third generation injectable cephalosporin or amoxicillin-clavulanate)

• able to take oral medication.

• has given its informed consent.

Exclusion Criteria:

• Creatinin < 30ml/min

• History of jaundice / hepatic impairment associated with amoxicillin / clavulanic acid

• History of hypersensitivity to beta-lactam

• Presence of complications or severity of pneumonia (abscess , significant pleural effusion, severe chronic respiratory failure , septic shock, respiratory condition requiring the passage resuscitation).

• Known immunocompromised terrain ( asplenia , neutropenia, agammaglobulinemia , immunosuppressants, graft corticosteroids , myeloma , lymphoma, known HIV , sickle cell anemia , CHILD C cirrhosis).

• Antibiotic treatment exceeding 24 hours prior admission.

• Suspected atypical bacteria requiring combined antibiotics therapy .(Subjects who received a single dose of macrolides or fluoroquinolones emergency will not be excluded) .

• Legionella suspected on clinical, biological and radiological criteria .

• Subjects with clinical or epidemiological environment leading to suspect a healthcare-associated pneumonia with antibiotic resistant pathogen.

• Suspicion of pneumonia by aspiration.

• Intercurrent infection requiring antibiotic treatment.

• Pregnant women .

• Breastfeeding .

• Allergy to antibiotics in use.

• Life expectancy <1 month .

• Subject without health insurance.

• Subjects without home adress

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Radiation:
• Chest X-ray
at Day 0, Day 30 and relapse

Biological:
• blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry

Drug:
• Augmentin
2 tablets 3 times a day for 5 days from Day 3
• Placebo (for Augmentin)
2 tablets 3 times a day for 5 days from Day 3
• Beta-Lactams
administered from Day 0 to Day 3

Locations

Country	Name	City	State
France	CH Argenteuil	Argenteuil
France	CHU Ambroise Paré	Boulogne-Billancourt
France	CH Beaujon	Clichy
France	CHI Creteil	Creteil
France	Central Hospital Raymon Poincaré	Garches
France	CHU de Grenoble	La Tronche
France	CH Versailles	Le Chesnay
France	CH Bicêtre	Le Kremlin Bicètre
France	Melun Hospital	Melun
France	CH d'Annecy Genevois	Metz-Tessy
France	CH Lariboisière	Paris
France	CH Tenon	Paris
France	CHU Bichat	Paris
France	CHU Cochin	Paris
France	CHU Saint Antoine	Paris
France	CH Pontoise	Pontoise
France	CHU Rennes Pontchaillou	Rennes
France	CHU Rouen	Rouen
France	CH Saint Denis	Saint Denis
France	Foch Hospital	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mortality all causes at Day 30		Day 30
Primary	clinical evaluation at Day 15	Clinical evaluation at Day 15 composed of the composite measure of the Clinical examination for clinical symptoms of CAP, recording of the body temperature and confirmation that no additionnal antibiotic treatment was required from Day 8	Day 15
Secondary	clinical evaluation at Day 30	Clinical evaluation at Day 30 composed of the composite measure of the Clinical examination for clinical symptoms of CAP, recording of the body temperature and Evaluation of replapse or aggravation of pneumonia or any other respiratory infections in subjects considered cured at Day 15.	Day 30