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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000265-36 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest X-ray | Radiation | at Day 0, Day 30 and relapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| mortality all causes at Day 30 | Day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Claude CREMIEUX, PH | Contact | 0033147107730 | anne-claude.cremieux@rpc.aphp.fr | |
| Aurélien DINH, Dr | Contact | aurelien.dinh@rpc.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Claude CREMIEUX, Pr | Central Hospital Raymon Poincaré | Principal Investigator |
| Marie Christine DOMBRET, Dr | CHU Bichat | Principal Investigator |
| Matthieu GROH, Dr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Argenteuil | Active, not recruiting | Argenteuil | 95107 | France | ||
| CHU Ambroise Paré |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38734138 | Derived | 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. | |
| 33773631 |
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| blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry | Biological |
|
| Augmentin | Drug | 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-Lactams | Drug | administered from Day 0 to Day 3 |
|
| 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 |
| Recruiting |
| Boulogne-Billancourt |
| 92100 |
| France |
|
| CH Beaujon | Recruiting | Clichy | 92110 | France |
|
| CHI Creteil | Recruiting | Créteil | 94000 | France |
|
| Central Hospital Raymon Poincaré | Recruiting | Garches | 92380 | France |
|
| CHU de Grenoble | Recruiting | La Tronche | 38700 | France |
|
| CH Versailles | Active, not recruiting | Le Chesnay | 78150 | France |
| CH Bicêtre | Recruiting | Le Kremlin Bicètre | 94275 | France |
|
| Melun Hospital | Recruiting | Melun | 77000 | France |
|
| CH d'Annecy Genevois | Active, not recruiting | Metz-Tessy | 74370 | France |
| CH Lariboisière | Recruiting | Paris | 75010 | France |
|
| CHU Saint Antoine | Active, not recruiting | Paris | 75012 | France |
| CHU Cochin | Withdrawn | Paris | 75014 | France |
| CHU Bichat | Withdrawn | Paris | 75018 | France |
| CH Tenon | Not yet recruiting | Paris | 75020 | France |
|
| CH Pontoise | Active, not recruiting | Pontoise | 95300 | France |
| CHU Rennes Pontchaillou | Withdrawn | Rennes | 35033 | France |
| CHU Rouen | Recruiting | Rouen | 76031 | France |
|
| CH Saint Denis | Active, not recruiting | Saint-Denis | 93205 | France |
| Foch Hospital | Recruiting | Suresnes | 92151 | France |
|
| 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. |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D001800 | Blood Specimen Collection |
| D002452 | Cell Count |
| D002097 | C-Reactive Protein |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D047090 | beta-Lactams |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003584 | Cytological Techniques |
| D002468 | Cell Physiological Phenomena |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D007162 | Immunoproteins |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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