Short Duration Treatment of Non-severe Community Acquired Pneumonia (PTC)

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)

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).

Study Overview

• Status: Unknown
• Conditions: Community Acquired Pneumonia
• Intervention / Treatment: Radiation: Chest X-ray; Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry; Drug: Augmentin; Drug: Beta-Lactams; Drug: Placebo (for Augmentin)

• Study Type: Interventional
• Enrollment (Anticipated): 310
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anne-Claude CREMIEUX, PH; Phone Number: 0033147107730; Email: anne-claude.cremieux@rpc.aphp.fr
• Study Contact Backup: Name: Aurélien DINH, Dr; Email: aurelien.dinh@rpc.aphp.fr

Study Locations

• France
  • Argenteuil, France, 95107
    • Active, not recruiting
    • CH Argenteuil
  • Boulogne-Billancourt, France, 92100
    • Recruiting
    • CHU Ambroise Pare
    • Sub-Investigator: Aurelien DINH, Dr
  • Clichy, France, 92110
    • Recruiting
    • CH Beaujon
    • Principal Investigator: Victoire De Lastours, Dr
  • Creteil, France, 94000
    • Recruiting
    • CHI Créteil
    • Principal Investigator: Valerie GARRAIT, Dr
  • Garches, France, 92380
    • Recruiting
    • Central Hospital Raymon Poincaré
    • Principal Investigator: Benjamin DAVIDO, PH
  • La Tronche, France, 38700
    • Recruiting
    • CHU de Grenoble
    • Principal Investigator: Jean-Paul STAHL, Dr
  • Le Chesnay, France, 78150
    • Active, not recruiting
    • CH Versailles
  • Le Kremlin Bicètre, France, 94275
    • Recruiting
    • Ch Bicetre
    • Principal Investigator: Benjamin WIPLOSZ, Pr
  • Melun, France, 77000
    • Recruiting
    • Melun Hospital
    • Principal Investigator: Sylvain DIAMANTIS, Dr
  • Metz-Tessy, France, 74370
    • Active, not recruiting
    • CH d'Annecy Genevois
  • Paris, France, 75010
    • Recruiting
    • CH Lariboisière
    • Principal Investigator: Véronique DELCEY, Dr
  • Paris, France, 75012
    • Active, not recruiting
    • CHU Saint Antoine
  • Paris, France, 75014
    • Withdrawn
    • CHU Cochin
  • Paris, France, 75018
    • Withdrawn
    • CHU Bichat
  • Paris, France, 75020
    • Not yet recruiting
    • CH Tenon
    • Principal Investigator: Gilles Pialoux, Dr
  • Pontoise, France, 95300
    • Active, not recruiting
    • CH Pontoise
  • Rennes, France, 35033
    • Withdrawn
    • CHU Rennes Pontchaillou
  • Rouen, France, 76031
    • Recruiting
    • CHU Rouen
    • Principal Investigator: Daniel BENHAMOU, Dr
  • Saint Denis, France, 93205
    • Active, not recruiting
    • CH Saint Denis
  • Suresnes, France, 92151
    • Recruiting
    • Foch Hospital
    • Principal Investigator: Jean-Emmanuel Kahn, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
mortality all causes at Day 30	Day 30

Collaborators and Investigators

• Sponsor: 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 Pare; 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 Créteil; Principal Investigator: Elena FOIS, Dr, CH Saint Denis; Principal Investigator: Benjamin WYPLOSZ, Pr, Ch Bicetre; 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

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2021 Jun 5;397(10290):2150.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin-Potassium Clavulanate Combination; Lactams; beta-Lactams
• Other Study ID Numbers: PHRC-12-202.0496 - PTC; 2013-000265-36 (EudraCT Number)