Trial · NCT01160640

The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)

NCT01160640, Phase 2, Completed, Harold Wiesenfeld; results first posted 2016-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID). Trials, record NCT01160640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01160640

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
NCT number: NCT01160640
Status: Completed
Phases: Phase 2
Enrollment: 233 participants, actual
Lead sponsor: Harold Wiesenfeld
Conditions: Pelvic Inflammatory Disease
Interventions: Ceftriaxone, Doxycycline, Metronidazole, Placebo Oral Capsule
First posted: 2010-07-12
Last updated: 2018-07-10
Results first posted: 2016-12-21

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clearance of Anaerobic Organisms From the Endometrium	Enrollment to 30 days	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.
Secondary	The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	enrollment	The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.
Secondary	The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.	Enrollment to 30 days	M. genitalium not detected in the cervical and endometrial cultures by nucleic acid amplification testing at the 30 day visit among women who had M. genitalium detected at either anatomical site at the enrollment visit.
Secondary	Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis	Enrollment to 3 day follow up visit	Clinical response to treatment is improvement (reduction) of the McCormack Scale total score from baseline to day 3 follow-up visit. Participants without a 3-day measure were considered treatment failures.
Secondary	Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.	enrollment	Identification of endometrial microorganisms present obtained from women with or without evidence of endometritis using a combination of culture methods, rRna sequencing and whole genomic sequencing. The aim is to identify the etiology of endometritis.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clearance of Anaerobic Organisms From the Endometrium	Enrollment to 30 days	Women who had anaerobic microorganisms detected in their endometrial biopsy sample at enrollment based on standard bacterial culture techniques.	participants	NUMBER
SECONDARY	The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	enrollment		participants	NUMBER
SECONDARY	The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.	Enrollment to 30 days	There were 34 women who had M. genitalium detected in the cervix or endometrium at enrollment who had test results from the 30-day visit.	participants	NUMBER
SECONDARY	Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis	Enrollment to 3 day follow up visit		participants	NUMBER
SECONDARY	Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.	enrollment	Women who had an endometrial sample that was sufficient for histologic assessment for endometritis.	participants	NUMBER

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Clearance of Anaerobic Organisms From the Endometrium	Ceftriaxone, Doxycycline, Placebo	Clearance of anaerobes	14	participants
Clearance of Anaerobic Organisms From the Endometrium	Ceftriaxone, Doxycycline, Metronidazole	Clearance of anaerobes	18	participants
Clearance of Anaerobic Organisms From the Endometrium	Ceftriaxone, Doxycycline, Placebo	Anaerobes detected	7	participants
Clearance of Anaerobic Organisms From the Endometrium	Ceftriaxone, Doxycycline, Metronidazole	Anaerobes detected	1	participants
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	Ceftriaxone, Doxycycline, Placebo	Detected in cervix only	16	participants
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	Ceftriaxone, Doxycycline, Metronidazole	Detected in cervix only	12	participants
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	Ceftriaxone, Doxycycline, Placebo	Detected in cervix and endometrium	8	participants
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	Ceftriaxone, Doxycycline, Metronidazole	Detected in cervix and endometrium	5	participants
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	Ceftriaxone, Doxycycline, Placebo	Detected in endometrium only	3	participants
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.	Ceftriaxone, Doxycycline, Metronidazole	Detected in endometrium only	2	participants

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ceftriaxone, Doxycycline, Placebo	117
Overall Study	STARTED	Ceftriaxone, Doxycycline, Metronidazole	116
Overall Study	COMPLETED	Ceftriaxone, Doxycycline, Placebo	113
Overall Study	COMPLETED	Ceftriaxone, Doxycycline, Metronidazole	110
Overall Study	NOT COMPLETED	Ceftriaxone, Doxycycline, Placebo	4
Overall Study	NOT COMPLETED	Ceftriaxone, Doxycycline, Metronidazole	6

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Placebo	55	117	59
other	Nausea	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Metronidazole	58	116	58
other	Vomiting	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Placebo	37	117	39
other	Vomiting	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Metronidazole	40	116	42
other	Diarrhea	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Placebo	30	117	30
other	Diarrhea	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Metronidazole	39	116	40
other	Vaginal discharge, abnormal	Reproductive system and breast disorders	Ceftriaxone, Doxycycline, Placebo	4	117	4
other	Vaginal discharge, abnormal	Reproductive system and breast disorders	Ceftriaxone, Doxycycline, Metronidazole	9	116	9
other	Altered taste	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Placebo	5	117	5
other	Altered taste	Gastrointestinal disorders	Ceftriaxone, Doxycycline, Metronidazole	8	116	8

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ceftriaxone, Doxycycline, Placebo
Total, all-cause mortality	Ceftriaxone, Doxycycline, Metronidazole
Total, other adverse events	Ceftriaxone, Doxycycline, Placebo	94	117
Total, other adverse events	Ceftriaxone, Doxycycline, Metronidazole	104	116
Total, serious adverse events	Ceftriaxone, Doxycycline, Placebo	5	117
Total, serious adverse events	Ceftriaxone, Doxycycline, Metronidazole	7	116

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32052831	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U19AI084024	The UPMC Sexually Transmitted Infections Cooperative Research Center	DARVILLE, TONI	UNIV OF NORTH CAROLINA CHAPEL HILL	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2009 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ceftriaxone, Doxycycline, Metronidazole vs Ceftriaxone, Doxycycline, Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01160640

GET https://conductscience.org/api/trials/v1/NCT01160640/results?page=2

API reference For AI assistants