Short Duration Treatment of Non-severe Community Acquired Pneumonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Central Hospital, Versailles
Sponsor:
Information provided by (Responsible Party):
Anne-claude Cremieux, Central Hospital, Versailles
ClinicalTrials.gov Identifier:
NCT01963442
First received: October 9, 2013
Last updated: July 11, 2014
Last verified: April 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Central Hospital, Versailles:

Primary Outcome Measures:
  • clinical evaluation at Day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 310
Study Start Date: November 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963442

Contacts
Contact: Anne-Claude CREMIEUX, PH 0033147107730 anne-claude.cremieux@rpc.aphp.fr

Locations
France
CH Argenteuil Recruiting
Argenteuil, France, 95107
Principal Investigator: Pascale LONGUET, Dr         
CHU Ambroise Paré Recruiting
Boulogne-Billancourt, France, 92100
Sub-Investigator: Aurelien DINH, Dr         
CHI Creteil Recruiting
Creteil, France, 94000
Principal Investigator: Valerie GARRAIT, Dr         
Central Hospital Raymon Poincaré Recruiting
Garches, France, 92380
Principal Investigator: Anne-Claude CREMIEUX, PH         
CH Versailles Active, not recruiting
Le Chesnay, France, 78150
Melun Hospital Recruiting
Melun, France, 77000
Principal Investigator: Sylvain DIAMANTIS, Dr         
CHU Saint Antoine Recruiting
Paris, France, 75012
Sub-Investigator: Nadia Valin, Dr         
CHU Bichat Recruiting
Paris, France, 75018
Principal Investigator: Marie-Christine DOMBRET, Pr         
CHU Cochin Active, not recruiting
Paris, France, 75014
CH Pontoise Recruiting
Pontoise, France, 95300
Principal Investigator: Jean-François BOITIAUX, Dr         
CHU Rouen Active, not recruiting
Rouen, France, 76031
CH Saint Denis Recruiting
Saint Denis, France, 93205
Principal Investigator: Elena FOIS, Dr         
Foch Hospital Recruiting
Suresnes, France, 92151
Principal Investigator: Jean-Emmanuel Kahn, Dr         
Sponsors and Collaborators
Central Hospital, Versailles
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
  More Information

No publications provided

Responsible Party: Anne-claude Cremieux, Clinical Coordinator, Central Hospital, Versailles
ClinicalTrials.gov Identifier: NCT01963442     History of Changes
Other Study ID Numbers: PHRC-12-202.0496 - PTC, 2013-000265-36
Study First Received: October 9, 2013
Last Updated: July 11, 2014
Health Authority: France: National Drug Security Agency (ANSM)

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Clavulanic Acids
Clavulanic Acid
Lactams
Amoxicillin-Potassium Clavulanate Combination
Beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014