NCT00002062

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

CryptosporidiosisHIV Infections

Keywords

SpiramycinAIDS-Related Opportunistic InfectionsImmune ToleranceCryptosporidiosisDiarrheaDrugs, InvestigationalAcquired Immunodeficiency Syndrome

Interventions

SpiramycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhone - Poulenc Rorer Pharmaceuticals

Horsham, Pennsylvania, 19044, United States

Location

MeSH Terms

Conditions

CryptosporidiosisHIV InfectionsAIDS-Related Opportunistic InfectionsDiarrheaAcquired Immunodeficiency Syndrome

Interventions

Spiramycin

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

LeucomycinsMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1991-10

Locations

US(1)