NCT00818610CompletedPhase 4
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.
Swiss National Fund for Scientific Research6 sites in 1 country601 target enrollmentStarted: January 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 601
- Locations
- 6
- Primary Endpoint
- Time to Clinical Stability (hours)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Monotherapy
Experimental
Intervention: Beta lactam (amoxicillin / clav. acid OR cefuroxime) (Drug)
Bi-therapy
Active Comparator
Intervention: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin) (Drug)
Outcomes
Primary Outcomes
Time to Clinical Stability (hours)
Time Frame: 30 days
Secondary Outcomes
- All cause mortality(in-hospital, at 30 and at 90 days)
- length of stay(30 days)
Investigators
Garin Nicolas
Associate physician
Swiss National Fund for Scientific Research
Study Sites (6)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Continuous vs. intermittent beta-lactam dosing in critically ill patients with sepsis: A randomized controlled trial.SepsisPACTR202009811610400Applied for and awaiting approval408
Completed
Phase 2
A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure InfectionsSoft Tissue InfectionsNCT00303589Hoffmann-La Roche313
Unknown
Not Applicable
Beta-lactam Therapeutic Drug Monitoring in SingaporeInfection, BacterialNCT04450680Singapore General Hospital80
Completed
Phase 2
Compare valproate Sodium and Levetiracetam effects on epilepsyIRCT2014083018973N1Deputy for research affairs of Shahrekord University of Medical Scince20
Completed
Not Applicable
Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.Sepsis or septic shockJPRN-UMIN000040688Juntendo University Urayasu Hospital825