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

Primary Purpose

Cryptosporidiosis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spiramycin
Sponsored by
Rhone-Poulenc Rorer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryptosporidiosis focused on measuring Spiramycin, AIDS-Related Opportunistic Infections, Immune Tolerance, Cryptosporidiosis, Diarrhea, Drugs, Investigational, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rhone - Poulenc Rorer Pharmaceuticals

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Rhone-Poulenc Rorer
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1. Study Identification

Unique Protocol Identification Number
NCT00002062
Brief Title
Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Official Title
Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rhone-Poulenc Rorer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptosporidiosis, HIV Infections
Keywords
Spiramycin, AIDS-Related Opportunistic Infections, Immune Tolerance, Cryptosporidiosis, Diarrhea, Drugs, Investigational, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Spiramycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rhone - Poulenc Rorer Pharmaceuticals
City
Horsham
State/Province
Pennsylvania
ZIP/Postal Code
19044
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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