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

NCT01160640 | Completed Phase 2 Results DMC

• 2 other identifiers: PRO100101121U19AI084024-01
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pelvic Inflammatory Disease

Keywords

PID; Pelvic Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• Clearance of Anaerobic Organisms From the Endometrium

  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.

  Enrollment to 30 days

Secondary Outcomes (4)

• The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.

  enrollment

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

  Enrollment to 30 days

• Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis

  Enrollment to 3 day follow up visit

• Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.

  enrollment

Study Arms (2)

Ceftriaxone/Doxycycline/Placebo Oral Cap

PLACEBO COMPARATOR

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; Drug: Doxycycline; Drug: Placebo Oral Capsule

Ceftriaxone, Doxycycline, Metronidazole

ACTIVE COMPARATOR

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; Drug: Doxycycline; Drug: Metronidazole

Interventions

Ceftriaxone DRUG

ceftrixone 250mg IM single dose

Also known as: Rocephin

Ceftriaxone, Doxycycline, Metronidazole; Ceftriaxone/Doxycycline/Placebo Oral Cap

Doxycycline DRUG

Doxycycline 100 mg PO bid x 14 days

Ceftriaxone, Doxycycline, Metronidazole; Ceftriaxone/Doxycycline/Placebo Oral Cap

Metronidazole DRUG

metronidazole 500 mg PO bid x 14 days

Also known as: Flagyl

Ceftriaxone, Doxycycline, Metronidazole

Placebo Oral Capsule DRUG

placebo oral capsule PO bid x 14 days

Ceftriaxone/Doxycycline/Placebo Oral Cap

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• Acute PID, defined by symptoms and signs guided by current CDC guidelines:50
• Current symptoms of lower abdominal or pelvic pain (present for ≤30 days) AND
• Cervical motion tenderness AND/OR uterine tenderness AND/OR adnexal tenderness on pelvic examination
• Ability to provide written informed consent

You may not qualify if:

• Women with any of the following will be ineligible to participate:
• Pregnant or nursing a baby (Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.)
• Uterine procedure (e.g. dilation and curettage, abortion) or miscarriage within the past 6 weeks.
• 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.
• Systemic or vaginal antibiotic therapy in the preceding 7 days
• Requires inpatient PID therapy (per the current CDC guidelines)50
• Inability to obtain an endometrial biopsy at enrollment
• Known inability to comply with the follow-up visits
• Prior hysterectomy
• 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)
• Inability to swallow pills
• Not willing to refrain from alcohol during the two week treatment period (and two additional days following completion of study medication)
• Other condition present at enrollment that requires additional antibiotic treatment
• Current use of any of the following medications:
• Anticoagulants, coumarin- or indandione-derivative: warfarin

Sponsors & Collaborators

• Harold Wiesenfeld: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Allegheny County Health Department Sexually Transmitted Diseases Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (1)

• Wiesenfeld HC, Meyn LA, Darville T, Macio IS, Hillier SL. A Randomized Controlled Trial of Ceftriaxone and Doxycycline, With or Without Metronidazole, for the Treatment of Acute Pelvic Inflammatory Disease. Clin Infect Dis. 2021 Apr 8;72(7):1181-1189. doi: 10.1093/cid/ciaa101.

  PMID: 32052831 DERIVED

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Interventions

Ceftriaxone; Doxycycline; Metronidazole

Condition Hierarchy (Ancestors)

Pelvic Infection; Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Harold Wiesenfeld
• Organization: University of Pittsburgh

wieshc@mail.magee.edu

412-641-1403

Study Officials

• Harold C Wiesenfeld, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 10, 2018
• Results First Posted: December 21, 2016

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)