Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia (BICAP)

Swiss National Fund for Scientific Research

Status and phase: Completed; Phase 4

Conditions: Community-acquired Pneumonia

Treatments: Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime); Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00818610

3200B0-120074/1

Details and patient eligibility

About

The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.

Enrollment: 601 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >=18 years
• New infiltrate on chest X-ray, unexplained by another disease process
• Presence of at least two of the following findings suggestive of pneumonia: fever or hypothermia, new or increasing cough, sputum production, pleuritic chest pain, tachypnea, dyspnea or focal signs on chest examination
• Need for hospitalization as defined by the emergency physician in charge of the patient

Exclusion criteria

• Allergy to one of the study drugs
• Pregnancy
• Severe immunosuppression
• Recent (<14 d) hospitalization, or currently hospitalized since > 48 hours
• Residency in a nursing home
• Previous use of more than 24 hours of any antibiotic
• Severe community-acquired pneumonia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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601 participants in 2 patient groups

Monotherapy

Experimental group

Treatment:

Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)

Bi-therapy

Active Comparator group

Treatment:

Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)