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

Phase 4

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime); Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)

• Registration Number: NCT00818610
• Lead Sponsor: Swiss National Fund for Scientific Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2013-01
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy	Beta lactam (amoxicillin / clav. acid OR cefuroxime)	-
Bi-therapy	Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)	-

Primary Outcome Measures

Name	Time	Method
Time to Clinical Stability (hours)	30 days

Secondary Outcome Measures

Name	Time	Method
All cause mortality	in-hospital, at 30 and at 90 days
length of stay	30 days

Trial Locations

Locations (6)

Hôpital Neuchâtelois - La Chaux-de-Fonds; 🇨🇭 La Chaux-de-Fonds, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Stadtspital Triemli; 🇨🇭 Zürich, Switzerland

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland

Centre Hospitalier du Centre du Valais; 🇨🇭 Sion, Valais, Switzerland

HFR-Fribourg, Hôpital Cantonal; 🇨🇭 Fribourg, Switzerland