Trial record 2 of 76 for:    pelvic inflammatory disease AND (woman OR women OR female)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Harold Wiesenfeld, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01160640
First received: July 8, 2010
Last updated: November 14, 2013
Last verified: November 2013
  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. 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.


Condition Intervention Phase
Pelvic Inflammatory Disease
Drug: ceftriaxone, doxycycline, and placebo
Drug: ceftriaxone, doxycycline, metronidazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Pittsburgh:

Primary Outcome Measures:
  • Clearance of anaerobic organisms from the endometrium [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The prevalence of M. genitalium in the cervix and endometrium from women with acute PID. [ Time Frame: enrollment ] [ Designated as safety issue: No ]
  • The eradication of M. genitalium from the lower and upper genital tract following antibiotic therapy for acute PID. [ Time Frame: 30 day follow up visit ] [ Designated as safety issue: No ]
  • Resolution of clinical signs and symptoms of acute PID [ Time Frame: 3 day follow up visit ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: specimens collected up to approximately 30 days ] [ Designated as safety issue: No ]
  • Determine immune response to Chlamydia trachomatis and other PID pathogens [ Time Frame: utilizing specimens collected up until approximately 30 days from enrollment ] [ Designated as safety issue: No ]
  • Identify frequencies of specific leukocyte cell populations in the endometrium of women with and without infection due to PID pathogens and determine the local cellular response to PID pathogens. [ Time Frame: up to 30 day study visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment Group A Drug: ceftriaxone, doxycycline, and placebo
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
Active Comparator: Treatment Group B Drug: 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

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160640

Contacts
Contact: Ingrid Macio, PA-C 412-641-5455 imacio@mail.magee.edu
Contact: Jamie Haggerty 412-641-5378 jhaggerty@mail.magee.edu

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Principal Investigator: Harold C Wiesenfeld, MD         
UPMC Mercy Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Principal Investigator: Harold C Wiesenfeld, MD         
Allegheny County Health Department Sexually Transmitted Diseases Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Principal Investigator: Harold C Wiesenfeld, MD         
Sponsors and Collaborators
Harold Wiesenfeld
Investigators
Principal Investigator: Harold C Wiesenfeld, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Harold Wiesenfeld, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01160640     History of Changes
Other Study ID Numbers: PRO10010112, 1U19AI084024-01
Study First Received: July 8, 2010
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
PID
Pelvic Inflammatory Disease

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

ClinicalTrials.gov processed this record on August 21, 2014