Short Duration Treatment of Non-severe Community Acquired Pneumonia
NCT ID: NCT01963442
Last Updated: 2017-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
310 participants
INTERVENTIONAL
2013-11-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Chest X-ray
at Day 0, Day 30 and relapse
blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
Augmentin
2 tablets 3 times a day for 5 days from Day 3
Beta-Lactams
administered from Day 0 to Day 3
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
Chest X-ray
at Day 0, Day 30 and relapse
blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
Placebo (for Augmentin)
2 tablets 3 times a day for 5 days from Day 3
Beta-Lactams
administered from Day 0 to Day 3
Interventions
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Chest X-ray
at Day 0, Day 30 and relapse
blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Versailles Hospital
OTHER
Responsible Party
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Anne-claude Cremieux
Clinical Coordinator
Principal Investigators
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Anne-Claude CREMIEUX, Pr
Role: PRINCIPAL_INVESTIGATOR
Central Hospital Raymon Poincaré
Marie Christine DOMBRET, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU Bichat
Matthieu GROH, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU Cochin
Elizabeth ROUVEIX, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU Ambroise Paré
Pascale LONGUET, Dr
Role: PRINCIPAL_INVESTIGATOR
CH Argenteuil
Daniel BENHAMOU, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU Rouen
Sylvain DIAMANTIS, Dr
Role: PRINCIPAL_INVESTIGATOR
Melun Hospital
Jean-Emmanuel Kahn, Dr
Role: PRINCIPAL_INVESTIGATOR
Foch Hospital
Jean-François BOITIAUX, Dr
Role: PRINCIPAL_INVESTIGATOR
Pontoise Hospital
Jean-Pierre BEDOS, Pr
Role: PRINCIPAL_INVESTIGATOR
Central Hospital of Versailles
Jêrome PACANOWSKI, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU Saint Antoine (Paris)
Valérie GARRAIT, Dr
Role: PRINCIPAL_INVESTIGATOR
CHI CRETEIL
Elena FOIS, Dr
Role: PRINCIPAL_INVESTIGATOR
CH Saint Denis
Benjamin WYPLOSZ, Pr
Role: PRINCIPAL_INVESTIGATOR
CH Bicêtre
Véronique DELCEY, Dr
Role: PRINCIPAL_INVESTIGATOR
CH Lariboisière
Gilles PIALOUX, Dr
Role: PRINCIPAL_INVESTIGATOR
CH Tenon
Matthieu REVEST, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes Pontchaillou
Jean Paul STAHL, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Virginie VITRAT, Dr
Role: PRINCIPAL_INVESTIGATOR
CH Annecy Genevois
Victoire De Lastours, Dr
Role: PRINCIPAL_INVESTIGATOR
CH Beaujon
Locations
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CH Argenteuil
Argenteuil, , France
CHU Ambroise Paré
Boulogne-Billancourt, , France
CH Beaujon
Clichy, , France
CHI Creteil
Créteil, , 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
CHU Saint Antoine
Paris, , France
CHU Cochin
Paris, , France
CHU Bichat
Paris, , France
CH Tenon
Paris, , France
CH Pontoise
Pontoise, , France
CHU Rennes Pontchaillou
Rennes, , France
CHU Rouen
Rouen, , France
CH Saint Denis
Saint-Denis, , France
Foch Hospital
Suresnes, , France
Countries
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Central Contacts
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References
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Dinh A, Duran C, Ropers J, Bouchand F, Deconinck L, Matt M, Senard O, Lagrange A, Mellon G, Calin R, Makhloufi S, de Lastours V, 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, Claessens YE, Labarere J, Bedos JP, Aegerter P, Cremieux AC; Pneumonia short treatment (PTC) study group. Exclusive oral antibiotic treatment for hospitalized community-acquired pneumonia: a post-hoc analysis of a randomized clinical trial. Clin Microbiol Infect. 2024 Aug;30(8):1020-1028. doi: 10.1016/j.cmi.2024.05.003. Epub 2024 May 9.
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.
Other Identifiers
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2013-000265-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHRC-12-202.0496 - PTC
Identifier Type: -
Identifier Source: org_study_id
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