An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the efficacy and safety of azithromycin given chronically for the treatment of Mycobacterium avium (MAC) bacteremia in patients failing or intolerant of current available MAC therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mycobacterium Avium-Intracellulare Infection HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azithromycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients must have:

* 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).
* At least 2 months of prior treatment with available combination MAC therapy or less than 2 months of such accompanied by unacceptable adverse effects.
* Life expectancy of more than 2 weeks.
* Approval of eligibility from Pfizer Clinical Monitor.
* Consent of parent or guardian if under legal age of consent.

NOTE:

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Known hypersensitivity or intolerance to macrolide antibiotics.
* Inability to take oral medications or current condition that is likely to interfere with absorption (e.g., gastrectomy).

Concurrent Medication:

Excluded:

* Other MAC therapy instituted during the first 2 months of the study.
* Other investigational drugs, with the exception of those available through a Treatment IND program.

Patients with the following prior conditions are excluded:

History of hypersensitivity or intolerance to azithromycin.

Prior Medication:

Excluded:

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

Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Central Research

Groton, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

066-162

Identifier Type: -

Identifier Source: secondary_id

058C