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NCT00097773 · ClinicalTrials.gov registry record · Phase 2
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
A Phase 2 study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 304
- Enrollment target
NCT00097773: Completed Phase 2 study, sponsored by Seattle Children's Hospital.
NCT00097773 is a Phase 2 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 304 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097773, a Phase 2 study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 304 participants
- Enrollment target
Study Summary
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.
Primary Outcome
The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups. Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns.
Interventions
- DRUG Oral placebo
- DRUG Tobramycin solution for inhalation (TOBI)
- DRUG Oral ciprofloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00097773 record still lists
NCT00097773 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher).
The record links to 0 conditions, and to 3 interventions - of which Oral placebo is the first listed.
NCT00097773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00097773 about?
NCT00097773 is a clinical study titled "Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis". Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to co...
What is the current status of trial NCT00097773?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 304 participants. The study started on 2004-09. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00097773?
The interventions under investigation include: Oral placebo (DRUG), Tobramycin solution for inhalation (TOBI) (DRUG), Oral ciprofloxacin (DRUG).
Who is sponsoring clinical trial NCT00097773?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00097773's enrollment target sits among peer trials
304 166th of 2000 higher than 1,834 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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