NCT00002328

Brief Summary

To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.

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

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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

July 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

CryptosporidiosisHIV Infections

Keywords

AntidiarrhealsCryptosporidiosisDiarrheaAcquired Immunodeficiency SyndromeAzithromycin

Interventions

AzithromycinDRUG

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Cryptosporidiosis infection.
  • Life expectancy of at least 1 week.
  • Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
  • Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.
  • Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Known hypersensitivity or significant intolerance to macrolide antibiotics.
  • Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.
  • Required:
  • Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Central Research

Groton, Connecticut, 06340, United States

Location

MeSH Terms

Conditions

CryptosporidiosisHIV InfectionsDiarrheaAcquired Immunodeficiency Syndrome

Interventions

Azithromycin

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 DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
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: 1998-07

Locations

US(1)