Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs

Launched by PFIZER · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.