Trial Outcomes & Findings for The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID) (NCT NCT01160640)
NCT ID: NCT01160640
Last Updated: 2018-07-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
233 participants
Primary outcome timeframe
Enrollment to 30 days
Results posted on
2018-07-10
Participant Flow
Participant milestones
| Measure |
Ceftriaxone, Doxycycline, Placebo
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
116
|
|
Overall Study
COMPLETED
|
113
|
110
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Ceftriaxone, Doxycycline, Placebo
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
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
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
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Incarceration
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
Baseline characteristics by cohort
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=117 Participants
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=116 Participants
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
24.7 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
76 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=5 Participants
|
116 participants
n=7 Participants
|
233 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to 30 daysPopulation: Women who had anaerobic microorganisms detected in their endometrial biopsy sample at enrollment based on standard bacterial culture techniques.
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.
Outcome measures
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=21 Participants
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=19 Participants
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
|---|---|---|
|
Clearance of Anaerobic Organisms From the Endometrium
Clearance of anaerobes
|
14 participants
|
18 participants
|
|
Clearance of Anaerobic Organisms From the Endometrium
Anaerobes detected
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: enrollmentThe number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.
Outcome measures
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=117 Participants
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=116 Participants
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
|---|---|---|
|
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.
Detected in cervix only
|
16 participants
|
12 participants
|
|
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.
Detected in cervix and endometrium
|
8 participants
|
5 participants
|
|
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.
Detected in endometrium only
|
3 participants
|
2 participants
|
|
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.
Not detected in cervix and endometrium
|
90 participants
|
97 participants
|
SECONDARY outcome
Timeframe: Enrollment to 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=21 Participants
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=13 Participants
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
|---|---|---|
|
The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.
Not detected in cervix & endometrium
|
8 participants
|
9 participants
|
|
The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.
Detected in cervix or endometrium
|
13 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Enrollment to 3 day follow up visitClinical 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.
Outcome measures
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=117 Participants
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=116 Participants
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
|---|---|---|
|
Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis
Clinical response
|
94 participants
|
96 participants
|
|
Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis
No response
|
23 participants
|
20 participants
|
SECONDARY outcome
Timeframe: enrollmentPopulation: Women who had an endometrial sample that was sufficient for histologic assessment for 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.
Outcome measures
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=70 Participants
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=138 Participants
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
|---|---|---|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Haemophilus influenzae
|
5 participants
|
1 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Chlamydia trachomatis
|
17 participants
|
5 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Neisseria gonorrhoeae
|
8 participants
|
2 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Mycoplasma genitalium
|
12 participants
|
5 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Gardnerella vaginalis
|
22 participants
|
25 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Atopobium vaginae
|
7 participants
|
13 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Anaerobic gram negative rods
|
8 participants
|
8 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Anaerobic gram positive cocci
|
10 participants
|
11 participants
|
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Anaerobic gram positive rods
|
4 participants
|
11 participants
|
Adverse Events
Ceftriaxone, Doxycycline, Placebo
Serious events: 5 serious events
Other events: 94 other events
Deaths: 0 deaths
Ceftriaxone, Doxycycline, Metronidazole
Serious events: 7 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=117 participants at risk
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=116 participants at risk
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
|---|---|---|
|
Reproductive system and breast disorders
Ruptured ovarian cyst, pelvic inflammatory disease increased pain
|
0.85%
1/117 • 2 months
|
0.00%
0/116 • 2 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.7%
2/117 • 2 months
|
0.00%
0/116 • 2 months
|
|
Reproductive system and breast disorders
Paratubal cyst, right
|
0.85%
1/117 • 2 months
|
0.00%
0/116 • 2 months
|
|
Nervous system disorders
Seizure
|
0.85%
1/117 • 2 months
|
0.00%
0/116 • 2 months
|
|
Reproductive system and breast disorders
Failed outpatient pelvic inflammatory disease treatment
|
0.00%
0/117 • 2 months
|
1.7%
2/116 • 2 months
|
|
Reproductive system and breast disorders
Pelvic pain, increased
|
0.00%
0/117 • 2 months
|
0.86%
1/116 • 2 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/117 • 2 months
|
0.86%
1/116 • 2 months
|
|
Reproductive system and breast disorders
Pelvic floor muscle spasm
|
0.00%
0/117 • 2 months
|
0.86%
1/116 • 2 months
|
|
Reproductive system and breast disorders
Acute pelvic inflammatory disease
|
0.00%
0/117 • 2 months
|
0.86%
1/116 • 2 months
|
|
Reproductive system and breast disorders
Pelvic inflammatory disease, nausea, and vomiting
|
0.00%
0/117 • 2 months
|
0.86%
1/116 • 2 months
|
Other adverse events
| Measure |
Ceftriaxone, Doxycycline, Placebo
n=117 participants at risk
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
|
Ceftriaxone, Doxycycline, Metronidazole
n=116 participants at risk
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
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
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
47.0%
55/117 • Number of events 59 • 2 months
|
50.0%
58/116 • Number of events 58 • 2 months
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
37/117 • Number of events 39 • 2 months
|
34.5%
40/116 • Number of events 42 • 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.6%
30/117 • Number of events 30 • 2 months
|
33.6%
39/116 • Number of events 40 • 2 months
|
|
Reproductive system and breast disorders
Vaginal discharge, abnormal
|
3.4%
4/117 • Number of events 4 • 2 months
|
7.8%
9/116 • Number of events 9 • 2 months
|
|
Gastrointestinal disorders
Altered taste
|
4.3%
5/117 • Number of events 5 • 2 months
|
6.9%
8/116 • Number of events 8 • 2 months
|
|
Infections and infestations
Bacterial vaginosis
|
6.8%
8/117 • Number of events 8 • 2 months
|
3.4%
4/116 • Number of events 4 • 2 months
|
|
General disorders
Headache
|
8.5%
10/117 • Number of events 10 • 2 months
|
10.3%
12/116 • Number of events 12 • 2 months
|
|
Gastrointestinal disorders
Loose stool
|
7.7%
9/117 • Number of events 9 • 2 months
|
5.2%
6/116 • Number of events 6 • 2 months
|
|
Reproductive system and breast disorders
Vaginal itching
|
6.0%
7/117 • Number of events 7 • 2 months
|
9.5%
11/116 • Number of events 11 • 2 months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
6.0%
7/117 • Number of events 8 • 2 months
|
15.5%
18/116 • Number of events 18 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place