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NCT00410527 · ClinicalTrials.gov registry record · Phase 4

Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients

A Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
Phase 4
Development phase

NCT00410527: Completed Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).

NCT00410527 is a Phase 4 study that has completed, run by National Institutes of Health Clinical Center (CC). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00410527, a Phase 4 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
Phase 4
Development phase

Study Summary

This study will compare two treatment strategies (standard versus short-course antibiotic therapy) for preventing resistant bacterial infection in patients in the intensive care unit (ICU). ICUs are the most frequently identified source of hospital-acquired infections. This study will examine the effectiveness of 3 days of antibiotic treatment in reducing the risk of developing antimicrobial-resistant bacteria as compared with standard antibiotic therapy of at least 8 days. It will also determine whether short-course therapy can reduce the duration and costs of ICU and hospital stays, of antibiotic treatment, and of costs involving treatment of infection-related problems. Patients of participating institutions who are in the ICU may be eligible for this study. Candidates must be 18 years of age or older. They must have been in the hospital for at least 3 days, developed new pulmonary infiltrates (fluid or cells in the airspaces of the lungs) during their ICU stay and must be at low risk of having pneumonia. Participants on short-course therapy take antibiotic for 3 days; those receiving standard therapy take antibiotic for at least 8 days. Both groups receive the treatment intravenously (through a vein). Sputum specimens are collected at baseline (before starting therapy) and on days 3, 10, and 28. Throat culture specimens are obtained at baseline and on days 3, 10, and 28. Nasal and anal or stool samples are collected at baseline and on days 10 and 28. Cultures of respiratory specimens obtained throughout the study period are examined for evidence of antimicrobial-resistant bacteria or the isolation of a potential pathogen. All patients are followed for 28 days after enrollment or until discharge from the hospital.

Interventions

  • DRUG Merrem

Trial Details

FieldValue
Start Date 2006-08-11
Est. Completion 2007-05-22
Phase Phase 4

What the finished NCT00410527 record still lists

NCT00410527 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 0 conditions, and to 1 intervention - of which Merrem is the first listed.

NCT00410527 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00410527 about?

NCT00410527 is a clinical study titled "Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients". This study will compare two treatment strategies (standard versus short-course antibiotic therapy) for preventing resistant bacterial infection in patients in the intensive care unit (ICU). ICUs are the most frequently identified source of hospital-acquired infections. This study will examine the ef...

What is the current status of trial NCT00410527?

This trial is currently completed. It is a Phase 4 study. The study started on 2006-08-11. Estimated completion is 2007-05-22.

What interventions are being tested in trial NCT00410527?

The interventions under investigation include: Merrem (DRUG).

Who is sponsoring clinical trial NCT00410527?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00410527, the US trial registry maintained by the National Library of Medicine. NCT00410527 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.