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NCT01160640 · ClinicalTrials.gov registry record · Phase 2
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
A Phase 2 study of Pelvic Inflammatory Disease, sponsored by Harold Wiesenfeld.
- Completed
- Registry status
- Phase 2
- Development phase
- 233
- Enrollment target
- 3
- Study locations
NCT01160640: Completed Phase 2 study of Pelvic Inflammatory Disease, sponsored by Harold Wiesenfeld.
NCT01160640 is a Phase 2 study of Pelvic Inflammatory Disease that has completed, run by Harold Wiesenfeld. The registered enrollment target is 233 participants, above the 116-participant average among 4 other Pelvic Inflammatory Disease trials with a reported enrollment target (101% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160640, a Phase 2 study of Pelvic Inflammatory Disease, has completed, sponsored by Harold Wiesenfeld.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 233 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is a randomized placebo-controlled trial comparing two antibiotic treatment regimens for acute PID. Women with acute PID will be randomized to one of two treatment regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally twice a day for 14 days, along with placebo tablets orally twice a day for 14 days or 2) same doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14 days. The primary objective is to compare the eradication of anaerobic organisms from the upper genital tract between women who receive standard outpatient antibiotic treatment to those who receive standard outpatient treatment along with a two-week course of metronidazole.
Primary Outcome
Clearance of anaerobic microorganisms from the endometrium at the 30 day follow-up visit among women who had anaerobic microorganisms detected in their endometrial tissue sample at enrollment. Clearance is defined as no anaerobic microorganisms detected in the endometrial tissue biopsy sample collected at the 30-day visit.
Conditions Studied
Interventions
- DRUG Placebo Oral Capsule
- DRUG Metronidazole
- DRUG Doxycycline
- DRUG Ceftriaxone
Study Locations (3)
Pennsylvania
- Allegheny County Health Department Sexually Transmitted Diseases Clinic - Pittsburgh
- Magee-Womens Hospital of UPMC - Pittsburgh
- UPMC Mercy Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT01160640 record still lists
NCT01160640 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 4 other Pelvic Inflammatory Disease trials with a reported enrollment target (101% higher).
The record links to 1 condition, with Pelvic Inflammatory Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebo Oral Capsule is the first listed.
NCT01160640 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01160640 about?
NCT01160640 is a clinical study titled "The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)". This study is a randomized placebo-controlled trial comparing two antibiotic treatment regimens for acute PID. Women with acute PID will be randomized to one of two treatment regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally twice a day for 14 days, along with...
What is the current status of trial NCT01160640?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 233 participants. The study started on 2010-11. Estimated completion is 2015-08.
What conditions does trial NCT01160640 study?
This clinical trial studies the following conditions: Pelvic Inflammatory Disease.
What interventions are being tested in trial NCT01160640?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Metronidazole (DRUG), Doxycycline (DRUG), Ceftriaxone (DRUG).
Who is sponsoring clinical trial NCT01160640?
This trial is sponsored by Harold Wiesenfeld, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01160640 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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