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OpenTrials
Completed

NCT Number: NCT00653172

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

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

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Key information

Conditions

Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NXL103

Drug

600mg orally twice daily

Comparator

Drug

comparator twice daily

Primary outcomes

  1. Evaluate Clinical outcome

    Time frame: early follow up visit (day 14 to 21)

Secondary outcomes

  1. Evaluate bacteriological outcome

    Time frame: early follow up visit (day 14 to 21)

  2. Evaluate safety

    Time frame: first dose, throughout treatment, and to follow up visit

Sponsors and collaborators

Lead sponsor

Novexel Inc

Industry

Registry information

Official study title

A Double-Blind, Multicenter, Randomized, Double Dummy, Three-Arm Parallel-Group Comparative Study of the Efficacy, Safety and Tolerance of Oral NXL 103 Versus Oral Comparator in the Treatment of Community-Acquired Pneumonia in Adults

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 4, 2008
Registry last updated
Jan 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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