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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Cryptosporidiosis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Spiramycin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Rhone - Poulenc Rorer Pharmaceuticals

Horsham, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CCA 901

Identifier Type: -

Identifier Source: secondary_id

011A