search
Back to results

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

Primary Purpose

Community Acquired Pneumonia

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Chest X-ray
blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
Augmentin
Placebo (for Augmentin)
Beta-Lactams
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Argenteuil
  • CHU Ambroise ParéRecruiting
  • CH BeaujonRecruiting
  • CHI CreteilRecruiting
  • Central Hospital Raymon PoincaréRecruiting
  • CHU de GrenobleRecruiting
  • CH Versailles
  • CH BicêtreRecruiting
  • Melun HospitalRecruiting
  • CH d'Annecy Genevois
  • CH LariboisièreRecruiting
  • CHU Saint Antoine
  • CHU Cochin
  • CHU Bichat
  • CH Tenon
  • CH Pontoise
  • CHU Rennes Pontchaillou
  • CHU RouenRecruiting
  • CH Saint Denis
  • Foch HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Amoxicillin/Clavulanic acid treatment

placebo treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 9, 2013
Last Updated
August 11, 2017
Sponsor
Versailles Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01963442
Brief Title
Short Duration Treatment of Non-severe Community Acquired Pneumonia
Acronym
PTC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin/Clavulanic acid treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo treatment
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Chest X-ray
Intervention Description
at Day 0, Day 30 and relapse
Intervention Type
Biological
Intervention Name(s)
blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
Intervention Type
Drug
Intervention Name(s)
Augmentin
Intervention Description
2 tablets 3 times a day for 5 days from Day 3
Intervention Type
Drug
Intervention Name(s)
Placebo (for Augmentin)
Intervention Description
2 tablets 3 times a day for 5 days from Day 3
Intervention Type
Drug
Intervention Name(s)
Beta-Lactams
Intervention Description
administered from Day 0 to Day 3
Primary Outcome Measure Information:
Title
clinical evaluation at Day 15
Description
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
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
clinical evaluation at Day 30
Description
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.
Time Frame
Day 30
Other Pre-specified Outcome Measures:
Title
mortality all causes at Day 30
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Claude CREMIEUX, PH
Phone
0033147107730
Email
anne-claude.cremieux@rpc.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélien DINH, Dr
Email
aurelien.dinh@rpc.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Claude CREMIEUX, Pr
Organizational Affiliation
Central Hospital Raymon Poincaré
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie Christine DOMBRET, Dr
Organizational Affiliation
CHU Bichat
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthieu GROH, Dr
Organizational Affiliation
CHU Cochin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth ROUVEIX, Pr
Organizational Affiliation
CHU Ambroise Paré
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascale LONGUET, Dr
Organizational Affiliation
CH Argenteuil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel BENHAMOU, Dr
Organizational Affiliation
CHU Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvain DIAMANTIS, Dr
Organizational Affiliation
Melun Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Emmanuel Kahn, Dr
Organizational Affiliation
Foch Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-François BOITIAUX, Dr
Organizational Affiliation
Pontoise Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Pierre BEDOS, Pr
Organizational Affiliation
Central Hospital of Versailles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jêrome PACANOWSKI, Dr
Organizational Affiliation
CHU Saint Antoine (Paris)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valérie GARRAIT, Dr
Organizational Affiliation
CHI Creteil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena FOIS, Dr
Organizational Affiliation
CH Saint Denis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin WYPLOSZ, Pr
Organizational Affiliation
CH Bicêtre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Véronique DELCEY, Dr
Organizational Affiliation
CH Lariboisière
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilles PIALOUX, Dr
Organizational Affiliation
CH Tenon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthieu REVEST, Dr
Organizational Affiliation
CHU Rennes Pontchaillou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Paul STAHL, Dr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginie VITRAT, Dr
Organizational Affiliation
CH Annecy Genevois
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoire De Lastours, Dr
Organizational Affiliation
CH Beaujon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Argenteuil
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Ambroise Paré
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelien DINH, Dr
Facility Name
CH Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoire De Lastours, Dr
Facility Name
CHI Creteil
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie GARRAIT, Dr
Facility Name
Central Hospital Raymon Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin DAVIDO, PH
Facility Name
CHU de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul STAHL, Dr
Facility Name
CH Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CH Bicêtre
City
Le Kremlin Bicètre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin WIPLOSZ, Pr
Facility Name
Melun Hospital
City
Melun
ZIP/Postal Code
77000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain DIAMANTIS, Dr
Facility Name
CH d'Annecy Genevois
City
Metz-Tessy
ZIP/Postal Code
74370
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CH Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique DELCEY, Dr
Facility Name
CHU Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Withdrawn
Facility Name
CH Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Pialoux, Dr
Facility Name
CH Pontoise
City
Pontoise
ZIP/Postal Code
95300
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Rennes Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel BENHAMOU, Dr
Facility Name
CH Saint Denis
City
Saint Denis
ZIP/Postal Code
93205
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Foch Hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Emmanuel Kahn, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
33773631
Citation
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.
Results Reference
derived

Learn more about this trial

Short Duration Treatment of Non-severe Community Acquired Pneumonia

We'll reach out to this number within 24 hrs