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NCT01594827 · ClinicalTrials.gov registry record · Phase 2
Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
A Phase 2 study of Cystic Fibrosis, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT01594827: Completed Phase 2 study of Cystic Fibrosis, sponsored by Johns Hopkins University.
NCT01594827 is a Phase 2 study of Cystic Fibrosis that has completed, run by Johns Hopkins University. The registered enrollment target is 29 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01594827, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA infection are needed. The purpose of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250 mg twice a day) or taste matched placebo and will be followed for 3 additional months. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled in this trial.
Primary Outcome
The hypothesis for our primary outcome is that the aggressive treatment arm will result in significantly greater eradication of persistent MRSA from the respiratory tract of CF adolescents and adults on day 58 (1 month after completion of therapy) compared to the placebo/standard treatment arm. Our primary outcome will be comparing the proportion of CF patients in the treatment arm who have a negative induced sputum MRSA culture at Day 58 to the proportion of patients in the placebo arm who have
Conditions Studied
Interventions
- DRUG Rifampin
- DRUG Doxycycline
- DRUG Inhaled Vancomycin
- DRUG Placebo (Sterile Water)
- DRUG Trimethoprim/Sulfamethoxazole (TMP/SMX)
Study Locations (2)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Ohio
- Rainbow Babies and Children's Hospital - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-12-30 |
| Phase | Phase 2 |
What the finished NCT01594827 record still lists
NCT01594827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 5 interventions - of which Rifampin is the first listed.
NCT01594827 reports a single indexed study location in Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT01594827 about?
NCT01594827 is a clinical study titled "Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)". The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and ...
What is the current status of trial NCT01594827?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2012-10. Estimated completion is 2017-12-30.
What conditions does trial NCT01594827 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01594827?
The interventions under investigation include: Rifampin (DRUG), Doxycycline (DRUG), Inhaled Vancomycin (DRUG), Placebo (Sterile Water) (DRUG), Trimethoprim/Sulfamethoxazole (TMP/SMX) (DRUG).
Who is sponsoring clinical trial NCT01594827?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01594827 being conducted?
This trial has 2 study locations across Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01594827's enrollment target sits among peer trials
29 120th of 169 higher than 50 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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