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Trial record 2 of 68 for:    pelvic inflammatory disease AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01160640
First Posted: July 12, 2010
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Harold Wiesenfeld, University of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Pelvic Inflammatory Disease Drug: Ceftriaxone Drug: Doxycycline Drug: Metronidazole Drug: Placebo Oral Capsule Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Importance of Anti-anaerobic Therapy for Acute PID

Resource links provided by NLM:


Further study details as provided by Harold Wiesenfeld, University of Pittsburgh:

Primary Outcome Measures:
  • Clearance of Anaerobic Organisms From the Endometrium [ Time Frame: 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 Outcome Measures:
  • The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID. [ Time Frame: enrollment ]
    The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.

  • The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID. [ Time Frame: 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.

  • Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis [ Time Frame: 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.

  • Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis. [ Time Frame: 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.


Enrollment: 233
Study Start Date: November 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ceftriaxone/Doxycycline/Placebo Oral Cap
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo oral capsule PO bid x 14 days
Drug: Ceftriaxone
ceftrixone 250mg IM single dose
Other Name: Rocephin
Drug: Doxycycline
Doxycycline 100 mg PO bid x 14 days
Drug: Placebo Oral Capsule
placebo oral capsule PO bid x 14 days
Active Comparator: Ceftriaxone, Doxycycline, Metronidazole
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
Drug: Ceftriaxone
ceftrixone 250mg IM single dose
Other Name: Rocephin
Drug: Doxycycline
Doxycycline 100 mg PO bid x 14 days
Drug: Metronidazole
metronidazole 500 mg PO bid x 14 days
Other Name: Flagyl

Detailed Description:
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. One group of women will receive 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. The second group of women will receive the 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 in women with acute PID who receive standard outpatient antibiotic treatment to the eradication of these organisms from the upper genital tract in women who receive standard outpatient treatment along with a two-week course of metronidazole. Women will be followed for one month for clinical outcomes, and will undergo assessment for clearance of microorganisms from the upper genital tract. Our hypothesis is that an antibiotic treatment regimen that includes anaerobic coverage will more effectively clear anaerobic organisms from the endometrium in women with acute PID compared to a standard antibiotic treatment regimen lacking effective antibiotic coverage against anaerobes.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women must meet all of the following inclusion criteria:

  1. Age 15-40 at the time of enrollment (Note: Participants between the ages of 15-17 will require written informed consent from parent/legal guardian. Written assent will also be obtained from the minor)
  2. Acute PID, defined by symptoms and signs guided by current CDC guidelines:50

    1. Current symptoms of lower abdominal or pelvic pain (present for ≤30 days) AND
    2. Cervical motion tenderness AND/OR uterine tenderness AND/OR adnexal tenderness on pelvic examination
  3. Ability to provide written informed consent

Exclusion Criteria:

Women with any of the following will be ineligible to participate:

  1. Pregnant or nursing a baby (Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.)
  2. Uterine procedure (e.g. dilation and curettage, abortion) or miscarriage within the past 6 weeks.
  3. Allergy to any of the study medications (cephalosporins, doxycycline, or metronidazole) or Type 1 hypersensitivity allergic reaction to penicillin for those with unknown tolerance to cephalosporins.
  4. Systemic or vaginal antibiotic therapy in the preceding 7 days
  5. Requires inpatient PID therapy (per the current CDC guidelines)50
  6. Inability to obtain an endometrial biopsy at enrollment
  7. Known inability to comply with the follow-up visits
  8. Prior hysterectomy
  9. Menopause (including natural menopause defined as lack of menses for 12 consecutive months [in the absence of pregnancy] and surgical menopause defined as a woman who has had both ovaries removed)
  10. Inability to swallow pills
  11. Not willing to refrain from alcohol during the two week treatment period (and two additional days following completion of study medication)
  12. Other condition present at enrollment that requires additional antibiotic treatment
  13. Current use of any of the following medications:

    • Anticoagulants, coumarin- or indandione-derivative: warfarin
    • cimetidine (Tagamet)
    • Disulfiram
    • Seizure medications including: phenytoin (Dilantin), carbamezapine (Tegretol), barbiturates (i.e. Phenobarbital)
    • Lithium
    • Immunosuppressive drugs including: cyclosporine, amprenavir
    • Antacids, minerals or bismuth subsalicylate (Pepto Bismol)
  14. Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes
  15. Participation in any study involving an investigational product in the past 30 days or anticipation of participation in any study using an investigational product in the next 30 days
  16. Previous participation in this study
  17. Evidence of a tuboovarian abscess
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160640


Locations
United States, Pennsylvania
Allegheny County Health Department Sexually Transmitted Diseases Clinic
Pittsburgh, Pennsylvania, United States, 15213
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
Harold Wiesenfeld
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Harold C Wiesenfeld, MD University of Pittsburgh
  More Information

Responsible Party: Harold Wiesenfeld, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01160640     History of Changes
Other Study ID Numbers: PRO10010112
1U19AI084024-01 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2010
First Posted: July 12, 2010
Results First Submitted: October 26, 2016
Results First Posted: December 21, 2016
Last Update Posted: September 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Harold Wiesenfeld, University of Pittsburgh:
PID
Pelvic Inflammatory Disease

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Adnexal Diseases
Genital Diseases, Female
Infection
Metronidazole
Doxycycline
Ceftriaxone
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Antimalarials