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Community Acquired PneumoniaPhase 2PTCNCT01963442

Short Duration Treatment of Non-severe Community Acquired Pneumonia

A Phase 2 study testing Chest X-ray, blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry and Augmentin in people with Community Acquired Pneumonia, run by Versailles Hospital at 20 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community Acquired Pneumonia
What is being tested?
Chest X-ray, blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry and Augmentin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
20 sitesFrance
Study dates
Nov 2013to Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

Anne-Claude CREMIEUX, PH contact

0033147107730

anne-claude.cremieux@rpc.aphp.fr

Aurélien DINH, Dr contact

aurelien.dinh@rpc.aphp.fr

20 sites in 1 country

France20 sites, 11 recruiting

  • CH Argenteuil

    Argenteuil, 95107

    Active, not recruiting

  • CHU Ambroise Paré

    Boulogne-Billancourt, 92100

    Aurelien DINH, Dr

    Recruiting

  • CH Beaujon

    Clichy, 92110

    Victoire De Lastours, Dr

    Recruiting

  • CHI Creteil

    Créteil, 94000

    Valerie GARRAIT, Dr

    Recruiting

  • Central Hospital Raymon Poincaré

    Garches, 92380

    Benjamin DAVIDO, PH

    Recruiting

  • CHU de Grenoble

    La Tronche, 38700

    Jean-Paul STAHL, Dr

    Recruiting

  • CH Versailles

    Le Chesnay, 78150

    Active, not recruiting

  • CH Bicêtre

    Le Kremlin Bicètre, 94275

    Benjamin WIPLOSZ, Pr

    Recruiting

  • Melun Hospital

    Melun, 77000

    Sylvain DIAMANTIS, Dr

    Recruiting

  • CH d'Annecy Genevois

    Metz-Tessy, 74370

    Active, not recruiting

  • CH Lariboisière

    Paris, 75010

    Véronique DELCEY, Dr

    Recruiting

  • CHU Saint Antoine

    Paris, 75012

    Active, not recruiting

  • CHU Cochin

    Paris, 75014

    Withdrawn

  • CHU Bichat

    Paris, 75018

    Withdrawn

  • CH Tenon

    Paris, 75020

    Gilles Pialoux, Dr

    Not yet recruiting

  • CH Pontoise

    Pontoise, 95300

    Active, not recruiting

  • CHU Rennes Pontchaillou

    Rennes, 35033

    Withdrawn

  • CHU Rouen

    Rouen, 76031

    Daniel BENHAMOU, Dr

    Recruiting

  • CH Saint Denis

    Saint-Denis, 93205

    Active, not recruiting

  • Foch Hospital

    Suresnes, 92151

    Jean-Emmanuel Kahn, Dr

    Recruiting

Other trials in France

About this study

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)

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).

Being tested
Chest X-ray, blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry, Augmentin, Placebo (for Augmentin), Beta-Lactams
Medical subject headings
Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chest X-rayRadiation

    at Day 0, Day 30 and relapse

  • blood sampling /Cell Counts/ C reactive protein (CRP)/BiochemistryBiological

  • AugmentinDrug

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

  • Placebo (for Augmentin)Drug

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

  • Beta-LactamsDrug

    administered from Day 0 to Day 3

Study groups in NCT01963442
Study groupRoleWhat they receive
Amoxicillin/Clavulanic acid treatmentActive comparatorafter 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
Receives: Radiation: Chest X-ray; Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry; Drug: Augmentin; Drug: Beta-Lactams
placebo treatmentPlacebo comparatorafter 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
Receives: Radiation: Chest X-ray; Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry; Drug: Placebo (for Augmentin); Drug: Beta-Lactams

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 15

Secondary outcomes (1)

  1. 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.

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJun 2018 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01963442
Sponsor's protocol ID
PHRC-12-202.0496 - PTC
Other IDs
2013-000265-36
Acronym
PTC
Status last verified
Aug 2017
First submitted
9 Oct 2013
Last updated
14 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38734138

  • 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.

    PubMed 33773631

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chest X-ray, blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry and Augmentin in people with Community Acquired Pneumonia, run by Versailles Hospital at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anne-Claude CREMIEUX, PH (0033147107730, anne-claude.cremieux@rpc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical evaluation at Day 15 (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01963442, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.

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