Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Completed · Not applicable
Conditions studied: Cryptosporidiosis, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002062
- Run by
- Rhone-Poulenc Rorer
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Rhone - Poulenc Rorer Pharmaceuticals — Horsham, Pennsylvania, United States
Full record on ClinicalTrials.gov
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