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

This study is currently recruiting participants.
Verified August 2017 by Anne-claude Cremieux, Versailles Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01963442
First Posted: October 16, 2013
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Anne-claude Cremieux, Versailles Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Anne-claude Cremieux, Versailles Hospital:

Primary Outcome Measures:
  • clinical evaluation at Day 15 [ Time Frame: 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


Secondary Outcome Measures:
  • clinical evaluation at Day 30 [ Time Frame: 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.


Other Outcome Measures:
  • mortality all causes at Day 30 [ Time Frame: Day 30 ]

Estimated Enrollment: 310
Study Start Date: November 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963442


Contacts
Contact: Anne-Claude CREMIEUX, PH 0033147107730 anne-claude.cremieux@rpc.aphp.fr
Contact: Aurélien DINH, Dr aurelien.dinh@rpc.aphp.fr

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

Responsible Party: Anne-claude Cremieux, Clinical Coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT01963442     History of Changes
Other Study ID Numbers: PHRC-12-202.0496 - PTC
2013-000265-36 ( EudraCT Number )
First Submitted: October 9, 2013
First Posted: October 16, 2013
Last Update Posted: August 14, 2017
Last Verified: August 2017

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors