To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies...
Date First Received: November 2, 1999
Last Updated: June 23, 2005
Verified by: NIH AIDS Clinical Trials Information Service, July 1998
Clinical Trial Phase: N/A | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy”
Condition Keyword(s):
Intervention(s):
To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Intervention(s) in this Clinical Trial
- Drug: Azithromycin
Criteria for Participation in this Clinical Trial
Inclusion Criteria
Patients must have:
- Cryptosporidiosis infection.
- Life expectancy of at least 1 week.
- Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
- Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.
- Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity or significant intolerance to macrolide antibiotics.
- Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.
Required:
- Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002328
Study ID Number: 058J
ClinicalTrials.gov Identifier: NCT00002328
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
