Trial Outcomes & Findings for Empiric Therapy of Mucopurulent Cervicitis (MPC) (NCT NCT01072136)
NCT ID: NCT01072136
Last Updated: 2014-12-24
Results Overview
The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 white blood cells per oil immersion field on cervical gram stain.
TERMINATED
PHASE3
87 participants
Visit 2 - 2 months (Day 50-70).
2014-12-24
Participant Flow
Participants were recruited from STD or family planning clinics in New Orleans, LA, Birmingham AL, Jackson, MS, and Los Angeles CA between March 2010 and May 2011.
Participant milestones
| Measure |
Azithromycin/Cefixime
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
Met All Enrollment Criteria
|
30
|
25
|
|
Overall Study
COMPLETED
|
21
|
12
|
|
Overall Study
NOT COMPLETED
|
23
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Empiric Therapy of Mucopurulent Cervicitis (MPC)
Baseline characteristics by cohort
| Measure |
Azithromycin/Cefixime
n=30 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=25 Participants
Placebo
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
25.8 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
25.8 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
25 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 - 2 months (Day 50-70).Population: Per protocol. Received study product, met eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.
The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 white blood cells per oil immersion field on cervical gram stain.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=21 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=12 Participants
Placebo
|
Clinical Cure
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC).
|
19 percentage of participants
|
33 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At 2-3 week and 2 month (Day 50-70) follow-up.Population: Participants who were randomized and received study product.
The number of participants experiencing PID after randomization.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=44 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=43 Participants
Placebo
|
Clinical Cure
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: At 2-3 week and 2 month (Day 50-70) follow-up.Population: Participants who were randomized and received study product.
The proportion of participants experiencing one or more adverse events after randomization.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=44 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=43 Participants
Placebo
|
Clinical Cure
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.
|
36.4 percentage of participants
|
27.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At 2 month (Day 50-70) follow-up.Population: Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas or cervical mycoplasma genitalium at 2 month follow-up.
Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 month follow-up according to asymptomatic bacterial vaginosis status at 2 month follow-up. Clinical Failure: * Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of \> 30 WBCs per oil immersion field on cervical gram stain OR * Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness. Partial Response: * Persistent cervical mucopus and/or easily induced cervical bleeding and \<30 WBCs per oil immersion field on cervical gram stain OR * The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding. Clinical Cure: • Absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 WBC's per oil immersion field on cervical gram stain.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=9 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=16 Participants
Placebo
|
Clinical Cure
n=7 Participants
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).
No Asymptomatic Bacterial Vaginosis
|
78 percentage of participants
|
88 percentage of participants
|
43 percentage of participants
|
|
Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).
Asymptomatic Bacterial Vaginosis
|
22 percentage of participants
|
13 percentage of participants
|
57 percentage of participants
|
SECONDARY outcome
Timeframe: At 2 month (Day 50-70) follow-up.Population: Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas at 2-month follow-up.
Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 months according to mycoplasma genitalium status(positive cervical or vaginal swabs versus both negative) at 2 months. Clinical Failure: * Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of \> 30 WBCs per oil immersion field on cervical gram stain OR * Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness. Partial Response: * Persistent cervical mucopus and/or easily induced cervical bleeding and \<30 WBCs per oil immersion field on cervical gram stain OR * The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding. Clinical Cure: • Absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 WBC's per oil immersion field on cervical gram stain.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=9 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=16 Participants
Placebo
|
Clinical Cure
n=7 Participants
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).
Negative for mycoplasma genitalium
|
100 percentage of participants
|
94 percentage of participants
|
100 percentage of participants
|
|
Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).
Positive for mycoplasma genitalium
|
0 percentage of participants
|
6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: At 2-3 weeks and 2 month (Day 50-70) follow-up.Population: Participants who were positive for mycoplasma genitalium in either the cervix or vagina at baseline and who met eligibility criteria and who returned for at least one of the follow-up visits.
The proportion of participants with mycoplasma genitalium at baseline who clear mycoplasma genitalium in either the vagina or cervix at their last follow-up visit.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=4 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=3 Participants
Placebo
|
Clinical Cure
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo.
|
2 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: At 2 month ( Day 50-70) follow-up.Population: Per protocol. Received study product, met all eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.
Clinical Failure: * Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of \> 30 WBCs per oil immersion field on cervical gram stain OR * Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness. Partial Response: * Persistent cervical mucopus and/or easily induced cervical bleeding and \<30 WBCs per oil immersion field on cervical gram stain OR * The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding. Clinical Cure: • Absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 WBC's per oil immersion field on cervical gram stain.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=21 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=12 Participants
Placebo
|
Clinical Cure
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm.
Clinical cure
|
19 percentage of participants
|
33 percentage of participants
|
—
|
|
Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm.
Partial response
|
43 percentage of participants
|
50 percentage of participants
|
—
|
|
Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm.
Clinical failure
|
38 percentage of participants
|
17 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At 2-3 weeks follow-up.Population: Received study product, met all eligibility criteria, and had complete outcome data at 2-3 weeks.
Clinical Failure: * Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of \> 30 WBCs per oil immersion field on cervical gram stain OR * Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness. Partial Response: * Persistent cervical mucopus and/or easily induced cervical bleeding and \<30 WBCs per oil immersion field on cervical gram stain OR * The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding. Clinical Cure: • Absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 WBC's per oil immersion field on cervical gram stain.
Outcome measures
| Measure |
Azithromycin/Cefixime
n=27 Participants
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=18 Participants
Placebo
|
Clinical Cure
Clinical Cure for mucopurulent cervicitis
|
|---|---|---|---|
|
Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm.
Clinical cure
|
7 percentage of participants
|
0 percentage of participants
|
—
|
|
Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm.
Partial response
|
41 percentage of participants
|
72 percentage of participants
|
—
|
|
Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm.
Clinical failure
|
52 percentage of participants
|
28 percentage of participants
|
—
|
Adverse Events
Azithromycin/Cefixime
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Azithromycin/Cefixime
n=44 participants at risk
A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
|
Placebo
n=43 participants at risk
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.5%
9/44 • Number of events 9
|
0.00%
0/43
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
7/44 • Number of events 7
|
0.00%
0/43
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • Number of events 4
|
2.3%
1/43 • Number of events 1
|
Additional Information
Shelly Lensing
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place