Pelvic Inflammatory DiseasePhase 2NCT01160640
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
A Phase 2 study testing Ceftriaxone, Doxycycline and Metronidazole in people with Pelvic Inflammatory Disease, run by Harold Wiesenfeld at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Ceftriaxone, Doxycycline and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women must meet all of the following inclusion criteria:
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- 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)
- Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes
- 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
- Previous participation in this study
- Evidence of a tuboovarian abscess
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Allegheny County Health Department Sexually Transmitted Diseases Clinic
Pittsburgh, Pennsylvania, 15213
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15219
About this study
Official title: The Importance of Anti-anaerobic Therapy for Acute 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 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.
Read the 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.
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Ceftriaxone, Doxycycline, Metronidazole, Placebo Oral Capsule
- Keywords
- PID, Pelvic Inflammatory Disease
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
Also called Rocephin
ceftrixone 250mg IM single dose
DoxycyclineDrug
Doxycycline 100 mg PO bid x 14 days
MetronidazoleDrug
Also called Flagyl
metronidazole 500 mg PO bid x 14 days
Placebo Oral CapsuleDrug
placebo oral capsule PO bid x 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ceftriaxone; Drug: Doxycycline; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment to 30 days
Secondary outcomes (4)
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.
The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.
Measured: enrollment
The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.
- 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.
Measured: Enrollment to 30 days
Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis
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.
Measured: Enrollment to 3 day follow up visit
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
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.
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harold Wiesenfeld
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Harold Wiesenfeld, University of Pittsburgh
- Investigators
- Harold C Wiesenfeld, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160640
- Sponsor's protocol ID
- PRO10010112
- Other IDs
- 1U19AI084024-01
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2010
- Last updated
- 10 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32052831
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Anti-anaerobic Therapy for Acute PID
- ClinicalTrials.gov ID
- NCT01160640
- Acronym / sponsor ID
- PRO10010112
- Conditions
- Pelvic Inflammatory Disease
- Keywords
- PID, Pelvic Inflammatory Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Harold WiesenfeldUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Posted 21 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone/Doxycycline/Placebo Oral Cap | Placebo comparator | Drug: Ceftriaxone, Drug: Doxycycline, Drug: Placebo Oral Capsuleceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo oral capsule PO bid x 14 days |
| Ceftriaxone, Doxycycline, Metronidazole | Active comparator | Drug: Ceftriaxone, Drug: Doxycycline, Drug: Metronidazoleceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- Ability to provide written informed consent
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftriaxoneAlso: Rocephinceftrixone 250mg IM single dose | Drug | Ceftriaxone, Doxycycline, Metronidazole, Ceftriaxone/Doxycycline/Placebo Oral Cap |
| DoxycyclineDoxycycline 100 mg PO bid x 14 days | Drug | Ceftriaxone, Doxycycline, Metronidazole, Ceftriaxone/Doxycycline/Placebo Oral Cap |
| MetronidazoleAlso: Flagylmetronidazole 500 mg PO bid x 14 days | Drug | Ceftriaxone, Doxycycline, Metronidazole |
| Placebo Oral Capsuleplacebo oral capsule PO bid x 14 days | Drug | Ceftriaxone/Doxycycline/Placebo Oral Cap |
Primary outcome
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.
4 secondary outcomes
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.
Time frame: 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
Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis
Time frame: Enrollment to 3 day follow up visit
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Time frame: enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32052831Wiesenfeld 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.
- Individual participant dataSharing planned: No
Related trials for Pelvic Inflammatory Disease
Not yet recruitingPhase 4
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Ulcerative Colitis (UC), Pouchitis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Cervical Carcinoma, Endometrial Carcinoma
RecruitingPhase 1/2
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Endometriosis, Adenomyosis
Not yet recruiting
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
Cesarean Section, Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold C Wiesenfeld, MD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceftriaxone, Doxycycline and Metronidazole in people with Pelvic Inflammatory Disease, run by Harold Wiesenfeld at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of Anaerobic Organisms From the Endometrium (time frame: Enrollment to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.