Clinical trial NCT01963442: Short Duration Treatment of Non-severe Community Acquired Pneumonia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Community Acquired Pneumonia
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: clinical evaluation at Day 15
timeFrame: Day 15
Secondary outcomes:
measure: clinical evaluation at Day 30
timeFrame: Day 30
Other outcomes:
measure: mortality all causes at Day 30
timeFrame: Day 30
Locations:
city: Argenteuil
country: France
facility: CH Argenteuil
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Clichy
country: France
facility: CH Beaujon
city: Creteil
country: France
facility: CHI Creteil
city: Garches
country: France
facility: Central Hospital Raymon Poincaré
city: La Tronche
country: France
facility: CHU de Grenoble
city: Le Chesnay
country: France
facility: CH Versailles
city: Le Kremlin Bicètre
country: France
facility: CH Bicêtre
city: Melun
country: France
facility: Melun Hospital
city: Metz-Tessy
country: France
facility: CH d'Annecy Genevois
city: Paris
country: France
facility: CH Lariboisière
city: Paris
country: France
facility: CHU Saint Antoine
city: Paris
country: France
facility: CHU Cochin
city: Paris
country: France
facility: CHU Bichat
city: Paris
country: France
facility: CH Tenon
city: Pontoise
country: France
facility: CH Pontoise
city: Rennes
country: France
facility: CHU Rennes Pontchaillou
city: Rouen
country: France
facility: CHU Rouen
city: Saint Denis
country: France
facility: CH Saint Denis
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Central Hospital Raymon Poincaré
name: Anne-Claude CREMIEUX, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Bichat
name: Marie Christine DOMBRET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Cochin
name: Matthieu GROH, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Ambroise Paré
name: Elizabeth ROUVEIX, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Argenteuil
name: Pascale LONGUET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Daniel BENHAMOU, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Melun Hospital
name: Sylvain DIAMANTIS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Foch Hospital
name: Jean-Emmanuel Kahn, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontoise Hospital
name: Jean-François BOITIAUX, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital of Versailles
name: Jean-Pierre BEDOS, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Saint Antoine (Paris)
name: Jêrome PACANOWSKI, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHI CRETEIL
name: Valérie GARRAIT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Saint Denis
name: Elena FOIS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Bicêtre
name: Benjamin WYPLOSZ, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Lariboisière
name: Véronique DELCEY, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Tenon
name: Gilles PIALOUX, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes Pontchaillou
name: Matthieu REVEST, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Jean Paul STAHL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Annecy Genevois
name: Virginie VITRAT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Beaujon
name: Victoire De Lastours, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dinh A, Ropers J, Duran C, Davido B, Deconinck L, Matt M, Senard O, Lagrange A, Makhloufi S, Mellon G, de Lastours V, Bouchand F, Mathieu E, Kahn JE, Rouveix E, Grenet J, Dumoulin J, Chinet T, Pepin M, Delcey V, Diamantis S, Benhamou D, Vitrat V, Dombret MC, Renaud B, Perronne C, Claessens YE, Labarere J, Bedos JP, Aegerter P, Cremieux AC; Pneumonia Short Treatment (PTC) Study Group. Discontinuing beta-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial. Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5.