Completed

Azithromycin Treatment for Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection

What is being tested

Azithromycin

Drug

Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

+12 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 treating patients who have a specific type of infection called Mycobacterium Avium-Intracellulare Complex (MAC). This infection is not responding well to current treatments. The study aims to help those who are experiencing symptoms and are either not improving with current therapies or cannot tolerate them. The goal is to find a new, effective treatment to manage this infection better. The treatment being tested in this study is a medication called azithromycin. Participants will take this medication regularly. The study will evaluate how well azithromycin works and how safe it is for treating MAC infections that are not responding to other treatments. It will monitor the participants' health and the infection's response to the medication.

NCT00002089

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 InfectionsMycobacterium Infections, NontuberculousRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeMycobacterium avium-intracellulare InfectionHIV Infections

Criteria

6 inclusion criteria required to participate

Exempt from inclusion criteria 1 and 2 and can continue therapy through this protocol if their physician feels they have benefitted from prior azithromycin therapy.

Disseminated MAC as defined by current (within the last month) positive blood, bone marrow, or liver biopsy culture for MAC, and considered symptomatic (fever, night sweats, anorexia, weight loss, fatigue, or malaise).

Life expectancy of more than 2 weeks.

Consent of parent or guardian if under legal age of consent.

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6 exclusion criteria prevent from participating

Known hypersensitivity or intolerance to macrolide antibiotics.

Other investigational drugs within 7 days of enrollment, with the exception of Treatment IND drugs (such as ddC).

Other investigational drugs, with the exception of those available through a Treatment IND program.

History of hypersensitivity or intolerance to azithromycin.

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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 1 location

Pfizer Central Research

Groton, United StatesOpen Pfizer Central Research in Google Maps

CompletedOne Study Center