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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Central Research
Groton, Connecticut, 06340 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cryptosporidiosis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00002328
Pfizer
Completed
Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs

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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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002328
058J
066-167S
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
July 1998

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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