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Search / Trial NCT00002328

Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs

Launched by PFIZER · Aug 30, 2001

Trial Information

Current as of June 12, 2025

Completed

Keywords

Antidiarrheals Cryptosporidiosis Diarrhea Acquired Immunodeficiency Syndrome Azithromycin

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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.

About Pfizer

Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.

Locations

Groton, Connecticut, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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