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

Versailles Hospital

Status and phase: Unknown; Phase 2

Conditions: Community Acquired Pneumonia

Treatments: Drug: Placebo (for Augmentin); Radiation: Chest X-ray; Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry; Drug: Augmentin; Drug: Beta-Lactams

Study type: Interventional

Funder types: Other

Identifiers

NCT01963442

2013-000265-36 (EudraCT Number)

PHRC-12-202.0496 - PTC

Details and patient eligibility

About

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).

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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310 participants in 2 patient groups, including a placebo group

Amoxicillin/Clavulanic acid treatment

Active Comparator group

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

Treatment:

Radiation: Chest X-ray

Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry

Drug: Augmentin

Drug: Beta-Lactams

placebo treatment

Placebo Comparator group

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

Treatment:

Radiation: Chest X-ray

Drug: Placebo (for Augmentin)

Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry

Drug: Beta-Lactams