PTC: Short Duration Treatment of Non-severe Community Acquired Pneumonia

Sponsor

Versailles Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01963442

Collaborator

(none)

310

Enrollment

Locations

Arms

Duration (Months)

15.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Community Acquired Pneumonia	Radiation: Chest X-ray Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry Drug: Augmentin Drug: Placebo (for Augmentin) Drug: Beta-Lactams	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

310 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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)

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Amoxicillin/Clavulanic acid treatment after 3 day treatment of β-lactams, the subjects receive 5-day treatment of Amoxicillin/clavulanic acid. Chest X-ray performed at admission and Day 30 and replapses. 'blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse	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 Drug: Beta-Lactams administered from Day 0 to Day 3
Placebo Comparator: placebo treatment after 3-day treatment of β-lactams, the subjects receive 5-day treatment of placebo. Chest X-ray performed at admission and Day 30 and replapse. blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse	Radiation: Chest X-ray at Day 0, Day 30 and relapse Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry Drug: Placebo (for Augmentin) 2 tablets 3 times a day for 5 days from Day 3 Drug: Beta-Lactams administered from Day 0 to Day 3

Arm

Intervention/Treatment

Active Comparator: Amoxicillin/Clavulanic acid treatment

after 3 day treatment of β-lactams, the subjects receive 5-day treatment of Amoxicillin/clavulanic acid. Chest X-ray performed at admission and Day 30 and replapses. 'blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse

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

Drug: Beta-Lactams

administered from Day 0 to Day 3

Placebo Comparator: placebo treatment

after 3-day treatment of β-lactams, the subjects receive 5-day treatment of placebo. Chest X-ray performed at admission and Day 30 and replapse. blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse

Radiation: Chest X-ray

at Day 0, Day 30 and relapse

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

Drug: Placebo (for Augmentin)

2 tablets 3 times a day for 5 days from Day 3

Drug: Beta-Lactams

administered from Day 0 to Day 3

Outcome Measures

Primary Outcome Measures

clinical evaluation at Day 15 [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

Secondary Outcome Measures

clinical evaluation at Day 30 [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.

Other Outcome Measures

mortality all causes at Day 30 [Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 β-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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Argenteuil	Argenteuil	France	95107
2	CHU Ambroise Paré	Boulogne-Billancourt	France	92100
3	CH Beaujon	Clichy	France	92110
4	CHI Creteil	Creteil	France	94000
5	Central Hospital Raymon Poincaré	Garches	France	92380
6	CHU de Grenoble	La Tronche	France	38700
7	CH Versailles	Le Chesnay	France	78150
8	CH Bicêtre	Le Kremlin Bicètre	France	94275
9	Melun Hospital	Melun	France	77000
10	CH d'Annecy Genevois	Metz-Tessy	France	74370
11	CH Lariboisière	Paris	France	75010
12	CHU Saint Antoine	Paris	France	75012
13	CHU Cochin	Paris	France	75014
14	CHU Bichat	Paris	France	75018
15	CH Tenon	Paris	France	75020
16	CH Pontoise	Pontoise	France	95300
17	CHU Rennes Pontchaillou	Rennes	France	35033
18	CHU Rouen	Rouen	France	76031
19	CH Saint Denis	Saint Denis	France	93205
20	Foch Hospital	Suresnes	France	92151

Sponsors and Collaborators

Versailles Hospital

Investigators

Principal Investigator: Anne-Claude CREMIEUX, Pr, Central Hospital Raymon Poincaré
Principal Investigator: Marie Christine DOMBRET, Dr, CHU Bichat
Principal Investigator: Matthieu GROH, Dr, CHU Cochin
Principal Investigator: Elizabeth ROUVEIX, Pr, CHU Ambroise Paré
Principal Investigator: Pascale LONGUET, Dr, CH Argenteuil
Principal Investigator: Daniel BENHAMOU, Dr, CHU Rouen
Principal Investigator: Sylvain DIAMANTIS, Dr, Melun Hospital
Principal Investigator: Jean-Emmanuel Kahn, Dr, Foch Hospital
Principal Investigator: Jean-François BOITIAUX, Dr, Pontoise Hospital
Principal Investigator: Jean-Pierre BEDOS, Pr, Central Hospital of Versailles
Principal Investigator: Jêrome PACANOWSKI, Dr, CHU Saint Antoine (Paris)
Principal Investigator: Valérie GARRAIT, Dr, CHI Creteil
Principal Investigator: Elena FOIS, Dr, CH Saint Denis
Principal Investigator: Benjamin WYPLOSZ, Pr, CH Bicêtre
Principal Investigator: Véronique DELCEY, Dr, CH Lariboisière
Principal Investigator: Gilles PIALOUX, Dr, CH Tenon
Principal Investigator: Matthieu REVEST, Dr, CHU Rennes Pontchaillou
Principal Investigator: Jean Paul STAHL, Dr, University Hospital, Grenoble
Principal Investigator: Virginie VITRAT, Dr, CH Annecy Genevois
Principal Investigator: Victoire De Lastours, Dr, CH Beaujon