- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002062
Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Horsham, Pennsylvania, United States, 19044
- Rhone - Poulenc Rorer Pharmaceuticals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Diseases, Parasitic
- Parasitic Diseases
- Protozoan Infections, Animal
- Parasitic Diseases, Animal
- Coccidiosis
- Protozoan Infections
- Cryptosporidiosis
- Diarrhea
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Coccidiostats
- Spiramycin
Other Study ID Numbers
- 011A
- CCA 901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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