Short Duration Treatment of Non-severe Community Acquired Pneumonia

NCT01963442 | Unknown Phase 2 DMC

• 2 other identifiers: PHRC-12-202.0496 - PTC2013-000265-36
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 20

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).

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• clinical evaluation at Day 30

  Day 30

Other Outcomes (1)

• mortality all causes at Day 30

  Day 30

Study Arms (2)

Amoxicillin/Clavulanic acid treatment

ACTIVE COMPARATOR

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; Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry; Drug: Augmentin; Drug: Beta-Lactams

placebo treatment

PLACEBO COMPARATOR

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; Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry; Drug: Placebo (for Augmentin); Drug: Beta-Lactams

Interventions

Chest X-ray RADIATION

at Day 0, Day 30 and relapse

Amoxicillin/Clavulanic acid treatment; placebo treatment

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

Amoxicillin/Clavulanic acid treatment; placebo treatment

Augmentin DRUG

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

Amoxicillin/Clavulanic acid treatment

Placebo (for Augmentin) DRUG

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

placebo treatment

Beta-Lactams DRUG

administered from Day 0 to Day 3

Amoxicillin/Clavulanic acid treatment; placebo treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (20)

CH Argenteuil

Argenteuil, 95107, France

ACTIVE NOT RECRUITING

CHU Ambroise Paré

Boulogne-Billancourt, 92100, France

RECRUITING

CH Beaujon

Clichy, 92110, France

RECRUITING

CHI Creteil

Créteil, 94000, France

RECRUITING

Central Hospital Raymon Poincaré

Garches, 92380, France

RECRUITING

CHU de Grenoble

La Tronche, 38700, France

RECRUITING

CH Versailles

Le Chesnay, 78150, France

ACTIVE NOT RECRUITING

CH Bicêtre

Le Kremlin Bicètre, 94275, France

RECRUITING

Melun Hospital

Melun, 77000, France

RECRUITING

CH d'Annecy Genevois

Metz-Tessy, 74370, France

ACTIVE NOT RECRUITING

CH Lariboisière

Paris, 75010, France

RECRUITING

CHU Saint Antoine

Paris, 75012, France

ACTIVE NOT RECRUITING

CHU Cochin

Paris, 75014, France

WITHDRAWN

CHU Bichat

Paris, 75018, France

WITHDRAWN

CH Tenon

Paris, 75020, France

NOT YET RECRUITING

CH Pontoise

Pontoise, 95300, France

ACTIVE NOT RECRUITING

CHU Rennes Pontchaillou

Rennes, 35033, France

WITHDRAWN

CHU Rouen

Rouen, 76031, France

RECRUITING

CH Saint Denis

Saint-Denis, 93205, France

ACTIVE NOT RECRUITING

Foch Hospital

Suresnes, 92151, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 38734138 DERIVED

• 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.

  PMID: 33773631 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

X-Rays; Blood Specimen Collection; Cell Count; C-Reactive Protein; Amoxicillin-Potassium Clavulanate Combination; beta-Lactams

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytological Techniques; Cell Physiological Phenomena; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Immunoproteins; Clavulanic Acid; Clavulanic Acids; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Claude CREMIEUX, PH

CONTACT

0033147107730; anne-claude.cremieux@rpc.aphp.fr

Aurélien DINH, Dr

CONTACT

aurelien.dinh@rpc.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Coordinator

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 16, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

FR (20)