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

To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cryptosporidiosis Acquired Immunodeficiency Syndrome Animal Diseases Blood-Borne Infections Coccidiosis Communicable Diseases Diarrhea Digestive System Diseases Gastrointestinal Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Intestinal Diseases, Parasitic Lentivirus Infections Parasitic Diseases Parasitic Diseases, Animal Pathological Conditions, Signs and Symptoms Protozoan Infections Protozoan Infections, Animal RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Signs and Symptoms, Digestive Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Central Research

Groton, Connecticut, 06340, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Azithromycin

Drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

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.

Published trials that share one or more normalized conditions with this study.

Completed