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Mucopurulent cervicitis (MPC) is a syndrome with associated symptoms including mucopurulent discharge (mucus and pus) from the cervix and other signs of inflammation such as easily induced cervical bleeding. The purpose of this study is to evaluate the effectiveness of no treatment versus empiric treatment with a single dose of cefixime and azithromycin for cure of MPC. Empiric treatment is the initiation of treatment prior to a firm diagnosis. Study participants will include 772 women ages 18 and older in good health with MPC. Women will be randomly assigned to 1 of 2 possible study groups: Group 1 will receive a single dose of cefixime and azithromycin antibiotics and Group 2 will receive placebo (inactive substance). Study procedures will include pelvic examination with a cervical swab sample. Participants will be involved in study related procedures for approximately 2 months, which includes 3 study visits.
Mucopurulent cervicitis (MPC) is a clinical syndrome characterized by the presence of mucopurulent discharge from the cervix and other signs of inflammation such as easily induced cervical bleeding. This phase III study is designed to evaluate the effectiveness of no treatment (placebo) versus empiric treatment with a single dose of cefixime 400 mg and azithromycin 1 gram for clinical cure of MPC at 2 months of follow-up. Secondary aims of the study are: to compare the pelvic inflammatory disease (PID) rate and adverse event rates between no treatment (placebo) versus empiric treatment; explore the role of bacterial vaginosis and Mycoplasma genitalium in the persistence of MPC; evaluate microbiological cure rate of M. genitalium in women treated with cefixime and azithromycin versus placebo; and present the clinical cure, partial response and failure proportions at 2-3 weeks and 2 months for each study arm. Participants will include 772 women greater than or equal to 18 years of age from Sexually Transmitted Disease (STD) or Family Planning (FP) clinics in good general health with MPC in New Orleans, LA; Birmingham, AL; Jackson, MS; Los Angeles, CA; and an additional site to be determined. Research specimens will be obtained at the time of the pelvic examination. As part of the study protocol, 3 cervical and 4 vaginal swabs will be collected at screening, follow-up visit 1, and follow-up visit 2. Eligible participants with clinical MPC at the time of their pelvic examination (cervical mucopus or easily induced cervical bleeding), will be consented, screened, enrolled, and randomized to one of the following arms: Group 1: empiric treatment: a single dose of cefixime 400 mg (1 capsule oral at 400 mg) and azithromycin 1 gm (2 capsules oral at 500 mg each) or Group 2: no treatment: placebo pills that look identical to the above medications. Subjects will be involved in study related procedures for 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo. |
|
| Azithromycin/Cefixime | Experimental | A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Capsule will be filled with lactose and be identical in appearance to the capsule with the active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC). | 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. | Visit 2 - 2 months (Day 50-70). |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment. | The number of participants experiencing PID after randomization. | At 2-3 week and 2 month (Day 50-70) follow-up. |
| Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Hospital - Infectious Diseases | Birmingham | Alabama | 35249-0001 | United States | ||
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Placebo | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC). | 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. | Per protocol. Received study product, met eligibility criteria, had complete primary outcome data, and absence of any major protocol violations. | Posted | Number | percentage of participants | Visit 2 - 2 months (Day 50-70). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
The study closed early due to slow accrual with 11% of the targeted sample size enrolled. Therefore, precision and power were low.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelly Lensing | University of Arkansas for Medical Sciences | 501-686-8203 | sylensing@uams.edu |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D002575 | Uterine Cervicitis |
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D020682 | Cefixime |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Azithromycin | Drug | Single dose will consist of 2 over-encapsulated capsules (500 mg each) administered orally. |
|
| Cefixime | Drug | Single dose will consist of 1 over-encapsulated capsule (400 mg) administered orally. |
|
The proportion of participants experiencing one or more adverse events after randomization. |
| At 2-3 week and 2 month (Day 50-70) follow-up. |
| Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC). | 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:
Partial Response:
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. | At 2 month (Day 50-70) follow-up. |
| Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC). | 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:
Partial Response:
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. | At 2 month (Day 50-70) follow-up. |
| Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo. | 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. | At 2-3 weeks and 2 month (Day 50-70) follow-up. |
| Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm. | Clinical Failure:
Partial Response:
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. | At 2 month ( Day 50-70) follow-up. |
| Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm. | Clinical Failure:
Partial Response:
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. | At 2-3 weeks follow-up. |
| Harbor UCLA Medical Center - OBGYN - General Gynecology and Women's Health |
| Torrance |
| California |
| 90502-2006 |
| United States |
| Louisiana Stte University - Health Sciences Center - Medicine | New Orleans | Louisiana | 70112-1349 | United States |
| University of Mississippi - Infectious Diseases | Jackson | Mississippi | 39216-4505 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
Placebo |
|
|
|
| Secondary | Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment. | The number of participants experiencing PID after randomization. | Participants who were randomized and received study product. | Posted | Number | participants | At 2-3 week and 2 month (Day 50-70) follow-up. |
|
|
|
| Secondary | Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment. | The proportion of participants experiencing one or more adverse events after randomization. | Participants who were randomized and received study product. | Posted | Number | percentage of participants | At 2-3 week and 2 month (Day 50-70) follow-up. |
|
|
|
| Secondary | Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC). | 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:
Partial Response:
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. | Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas or cervical mycoplasma genitalium at 2 month follow-up. | Posted | Number | percentage of participants | At 2 month (Day 50-70) follow-up. |
|
|
|
| Secondary | Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC). | 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:
Partial Response:
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. | Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas at 2-month follow-up. | Posted | Number | percentage of participants | At 2 month (Day 50-70) follow-up. |
|
|
|
| Secondary | Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo. | 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. | 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. | Posted | Number | participants | At 2-3 weeks and 2 month (Day 50-70) follow-up. |
|
|
|
| Secondary | Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm. | Clinical Failure:
Partial Response:
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. | Per protocol. Received study product, met all eligibility criteria, had complete primary outcome data, and absence of any major protocol violations. | Posted | Number | percentage of participants | At 2 month ( Day 50-70) follow-up. |
|
|
|
| Secondary | Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm. | Clinical Failure:
Partial Response:
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. | Received study product, met all eligibility criteria, and had complete outcome data at 2-3 weeks. | Posted | Number | percentage of participants | At 2-3 weeks follow-up. |
|
|
|
| 0 |
| 44 |
| 11 |
| 44 |
| EG001 | Placebo | Placebo | 0 | 43 | 1 | 43 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D016870 | Neisseriaceae Infections |
| Organic Chemicals |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|
|
| Clinical failure |
|
| Clinical failure |
|