Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients

This protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile.

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Key information

Conditions

Cryptosporidiosis AIDS-Related Opportunistic Infections 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 Opportunistic 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhone - Poulenc Rorer Pharmaceuticals

Horsham, Pennsylvania, 19044, United States

Who can participate

Healthy volunteers accepted: No

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

Exclusion criteria

Co-existing Condition:

Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.

Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Concurrent Medication:

Excluded:

Other investigational drugs.

Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Prior Medication:

Excluded within 7 days of study entry:

Other investigational drugs.

Diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS.

Patients receiving chemotherapy for a malignancy.
Patients who are iatrogenically immune-suppressed following organ transplantation.

Treatment and study plan

Spiramycin

Drug

Sponsors and collaborators

Lead sponsor

Rhone-Poulenc Rorer

Industry

Registry information

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