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Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia

Beta-lactam Monotherapy Versus Beta-lactam - Macrolide Association as Empiric Antibiotherapy Strategies in Non-severe Hospitalized Community-acquired Pneumonia: a Randomized, Non-inferiority, Open Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00818610
Acronym
BICAP
Enrollment
601
Registered
2009-01-07
Start date
2009-01-31
Completion date
2013-04-30
Last updated
2013-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired infections, Pneumonia, Clinical Stability, Antibiotics, Combination therapy, Atypical bacteria

Brief summary

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.

Interventions

DRUGBeta lactam (amoxicillin / clav. acid OR cefuroxime)

1.2 g 4x/d OR 1.5 g 3x/d IV

DRUGBeta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)

1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO

Sponsors

University Hospital, Geneva
CollaboratorOTHER
Swiss National Fund for Scientific Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to Clinical Stability (hours)30 days

Secondary

MeasureTime frame
All cause mortalityin-hospital, at 30 and at 90 days
length of stay30 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026