---
title: Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
nct_id: NCT00004296
overall_status: COMPLETED
sponsor: National Center for Research Resources (NCRR)
study_type: OBSERVATIONAL
primary_condition: Cystic Fibrosis
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00004296.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00004296"
ct_last_update_post_date: 2005-06-24
last_seen_at: "2026-05-12T06:14:03.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

**NCT ID:** [NCT00004296](https://clinicaltrials.gov/study/NCT00004296)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 1000
- **Lead Sponsor:** National Center for Research Resources (NCRR)
- **Collaborators:** University of North Carolina
- **Conditions:** Cystic Fibrosis, Atypical Mycobacterium Infection
- **Start Date:** 1995-09
- **CT.gov Last Update:** 2005-06-24

## Brief Summary

OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures from patients with cystic fibrosis.

II. Compare the clinical course of patients with negative versus positive cultures.

## Detailed Description

PROTOCOL OUTLINE: Participants are screened for nontuberculous mycobacteria (NTM) with 3 sputum acid-fast bacilli smears and mycobacterial cultures, with speciation of positive cultures, collected over 1 year. Demographic data, diagnostic criteria, clinical measurements, and other respiratory pathogen data are collected using the Cystic Fibrosis Foundation Patient Registry Questionnaire.

NTM-positive patients (cases) matched with NTM-negative controls identified in screening are followed every 3 months for 15 months. Cases are evaluated for NTM burden during the first 3 months.

Appropriate therapy is offered to consistently NTM-positive cases. Lung transplant recipients are removed from study.

## Eligibility

- **Minimum age:** 10 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
PROTOCOL ENTRY CRITERIA:

Patients over age 10 with cystic fibrosis documented as follows:

* Pilocarpine sweat chloride test at least 60 mEq/L OR
* Genotyping or transepithelial potential difference AND
* Clinical symptoms of suppurative respiratory disease or pancreatic insufficiency

Able to produce at least 3 sputum samples

* Bronchoscopy specimens acceptable
* Throat/nasal specimens not acceptable

No Pseudomonas cepacia colonization
```

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00004296.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00004296*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*