Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Launched by RHONE-POULENC RORER · Aug 30, 2001
Trial Information
Current as of July 07, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • 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 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.
- 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.
About Rhone Poulenc Rorer
Rhone-Poulenc Rorer, a prominent global pharmaceutical company, specializes in the research, development, and commercialization of innovative therapeutic solutions across various medical fields. With a strong commitment to advancing healthcare, the company focuses on delivering high-quality pharmaceuticals that address unmet medical needs, emphasizing rigorous clinical trials and regulatory compliance. Leveraging its extensive expertise in drug development and a collaborative approach, Rhone-Poulenc Rorer aims to enhance patient outcomes and contribute to the overall well-being of communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Horsham, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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