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Completed

NCT Number: NCT00648726

An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia

To validate the efficacy and safety of azithromycin for the treatment of Chinese patients hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the combination of cefuroxime plus oral erythromycin.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion criteria

  • Patients hospitalized with a diagnosis of community acquired pneumonia (CAP) as defined by the presence of new infiltrate(s) including manifestation of consolidation, patchy, diffuse or interstitial inflammation on chest X-ray with or without pleural effusion plus at least 1 of the following: new cough and expectoration or progression of respiratory symptoms with purulent sputum with or without chest pain; fever; auscultatory findings such as rales or evidence of pulmonary consolidation; blood leukocyte count >10×109/L or <4×109/L with or without >15% bands or a blood leukocyte count between 4 and 10 with neutropils greater than or equal to 75%

Exclusion criteria

Exclusion criteria

  • Patients with hospital acquired pneumonia, aspiration pneumonia, severe pneumonia, history of post-obstructive pneumonia, active tuberculosis or bronchitis, bronchiectasis or chronic obstructive pulmonary disease without evidence of acute infection were not eligible for this study
  • Patients treated with any systemic antibiotic within 72 hours prior to study entry were not eligible unless the medication was, in the opinion of the investigators, classified as having failed

Treatment and study plan

cefuroxime plus erythromycin

Drug

intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days plus erythromycin ethylsuccinate 0.5 g twice daily, which was given for a total duration of 14 days for subjects with suspected pneumonia due to atypical pathogens

azithromycin (Zithromax)

Drug

intravenous azithromycin 500 mg once daily for 4 +/-1 days, followed by oral azithromycin 500 mg once daily for a total duration of 9 +/-1 days

cefuroxime

Drug

intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days

Primary outcomes

  1. clinical efficacy (cure or marked improvement)

    Time frame: Visit 3 (Day 9 +-1 of treatment)

Secondary outcomes

  1. bacteriological efficacy (eradication)

    Time frame: Visit 3

  2. clinical efficacy

    Time frame: Visit 4 (8 +/-1 days after treatment)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open, Prospective, Randomized, Multi-Center Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin vs. Cefuroxime Monotherapy or Plus Oral Erythromycin for the Treatment of Chinese Hospitalized Patients With Community- Acquired Pneumonia

Important dates

Study start
2003
Study completion
2003
First posted
Apr 1, 2008
Registry last updated
Apr 1, 2008

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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