Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cryptosporidiosis HIV Infections |
Drug: Spiramycin |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002062 History of Changes |
| Other Study ID Numbers: | 011A, CCA 901 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Spiramycin AIDS-Related Opportunistic Infections Immune Tolerance Cryptosporidiosis |
Diarrhea Drugs, Investigational Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Cryptosporidiosis Diarrhea Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Intestinal Diseases, Parasitic Parasitic Diseases |
Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive Signs and Symptoms Spiramycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Coccidiostats |
ClinicalTrials.gov processed this record on May 22, 2013