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NCT01744730 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile
A Phase 1 study of Obesity and Bacterial Infections, sponsored by Phillip Brian Smith.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 4
- Study locations
NCT01744730: Completed Phase 1 study of Obesity and Bacterial Infections, sponsored by Phillip Brian Smith.
NCT01744730 is a Phase 1 study of Obesity and Bacterial Infections that has completed, run by Phillip Brian Smith. The registered enrollment target is 22 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01744730, a Phase 1 study of Obesity and Bacterial Infections, has completed, sponsored by Phillip Brian Smith.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The results of the study will help better understand if children in higher BMI ranges process the medication differently and whether dosing should be adjusted in these children.
Primary Outcome
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN\_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN\_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
Conditions Studied
Interventions
- DRUG Clindamycin
Study Locations (4)
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago
Kansas
- Children's Mercy Hospital - Kansas City
Kentucky
- University of Louisville - Louisville
Ohio
- Akron Children's Hospital - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01744730 record still lists
NCT01744730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Clindamycin is the first listed.
NCT01744730 reports a single indexed study location in Illinois, Kansas, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01744730 about?
NCT01744730 is a clinical study titled "Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile". The purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The results of the study will help better understand if children in higher BMI ranges process the medication differen...
What is the current status of trial NCT01744730?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2013-06. Estimated completion is 2014-08.
What conditions does trial NCT01744730 study?
This clinical trial studies the following conditions: Obesity, Bacterial Infections.
What interventions are being tested in trial NCT01744730?
The interventions under investigation include: Clindamycin (DRUG).
Who is sponsoring clinical trial NCT01744730?
This trial is sponsored by Phillip Brian Smith, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01744730 being conducted?
This trial has 4 study locations across Illinois, Kansas, Kentucky, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
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 NCT01744730's enrollment target sits among peer trials
22 935th of 1053 higher than 116 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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