Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia

Phase 2

Completed

• Conditions: Community Acquired Pneumonia
• Interventions: Drug: NXL103; Drug: comparator

• Registration Number: NCT00653172
• Lead Sponsor: Novexel Inc

Brief Summary

The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Primary Completion: 2008-06
• Study Completion: 2008-11
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-08
• Last Update Posted: 2009-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• Community acquired pneumonia

Exclusion Criteria

• severe CAP
• respiratory infections attributed to sources other than community acquired bacterial infection
• concomitant pulmonary disease
• history of hypersensitivity to study medication, macrolide or beta lactam antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	NXL103	NXL103
1	NXL103	NXL103
3	comparator	-

Primary Outcome Measures

Name	Time	Method
Evaluate Clinical outcome	early follow up visit (day 14 to 21)

Secondary Outcome Measures

Name	Time	Method
Evaluate bacteriological outcome	early follow up visit (day 14 to 21)
Evaluate safety	first dose, throughout treatment, and to follow up visit

Trial Locations

Locations (60)

Clinica de Enfermedades Resp. "Miguel de Servet" SA; 🇨🇱 Santiago, Chile

Complejo Asistencial Barros Luco Trudeau; 🇨🇱 Santiago, Chile

Hospital de Urgencia Asistencia Publica; 🇨🇱 Santiago, Chile

Hospital Regional de Rancagua; 🇨🇱 Santiago, Chile

Clinic for infectious diseases; 🇭🇷 Zagreb, Croatia

General Hospital Sveti Duh; 🇭🇷 Zagreb, Croatia

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia

Linnamoisa Perearstikeskus; 🇪🇪 Tallinn, Estonia

Merelahe Family Doctors Centre; 🇪🇪 Tallinn, Estonia

Nolvaku Family Doctor Center; 🇪🇪 Tartu, Estonia

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