Completed

Azithromycin for Serious Nontuberculous Mycobacterial Disease Treatment in Intolerant or Failing Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Azithromycin

Drug
Who is being recruted

Blood-Borne Infections+21

+ Urogenital Diseases

+ Genital Diseases

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on the treatment of serious nontuberculous mycobacterial disease, a type of bacterial infection that isn't tuberculosis. It's designed for patients who aren't responding well to other available treatments or who can't tolerate them. The goal is to see if a drug called azithromycin can help these patients. The importance of this study lies in finding new treatment options for this serious condition, especially for those who aren't benefiting from current therapies. During this study, participants receive azithromycin on an ongoing basis. The study aims to evaluate how well and safely this drug works for treating serious nontuberculous mycobacterial disease. It measures the results by looking at the patients' response to the treatment, including any improvements in their condition and any side effects they might experience.

NCT00002085
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeMycobacterium Infections, NontuberculousTuberculosisMycobacterium avium-intracellulare InfectionHIV Infections

Criteria

3 inclusion criteria required to participate
Approval of eligibility from Pfizer Clinical Monitor. Patients below the legal age of consent must have consent of parent or guardian
Serious nontuberculous mycobacterial infection
Other antimicrobial drugs as long as documented on Case Report Form
3 exclusion criteria prevent from participating
Disseminated Mycobacterium avium complex (MAC) who are eligible for treatment with azithromycin under protocol 066-162
History of hypersensitivity or intolerance to azithromycin
Known hypersensitivity or intolerance to macrolide antibiotics

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Pfizer Central Research

Groton, United StatesOpen Pfizer Central Research in Google Maps

Natl Cancer Institute / Metabolism Branch

Bethesda, United States
Completed2 Study Centers