Vaginitis BacterialPhase 3NCT01072136
Empiric Therapy of Mucopurulent Cervicitis (MPC)
A Phase 3 study testing Azithromycin and Cefixime in people with Vaginitis Bacterial and Cervicitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginitis Bacterial, Cervicitis
- What is being tested?
- Azithromycin and Cefixime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women greater than or equal to 18 years old in Sexually Transmitted Disease (STD) clinics or Family Planning clinics.
- Presence of cervical mucopus and/or easily induced cervical bleeding on pelvic exam via endocervical swab.
- Greater than or equal to 30 white blood cells (WBCs) per high power field in the cervical Gram stain. (Note: the cervical Gram stains will be sent to a central lab for review. The results will not be available at the time of enrollment. Subjects who do not meet this criterion will be withdrawn from the study at the time the results are available).
- Willingness to provide written informed consent
- Willing to abstain from sexual intercourse or use condoms during the entire study (approximately 2 months).
- Willing to abstain from using vaginal products during the entire study (approximately 2 months).
Who cannot join
- Signs and symptoms of pelvic inflammatory disease, including cervical motion, uterine, or adnexal tenderness.
- History of pelvic inflammatory disease (PID), ectopic pregnancy or recurrent cervicitis (3 or more episodes in the prior year) or written documentation of recent cervicitis (within past 30 days).
- Gonorrhea or Chlamydia on nucleic acid amplification test (NAAT) at time of enrollment. (Participant testing positive for Neisseria gonorrhoeae (GC) or Chlamydia trachomatis (CT) on enrollment visit sample will be discontinued).
- Women with motile trichomonas on wet mount examination or positive trichomonas culture at time of enrollment.
- Women with symptomatic bacterial vaginosis (BV) (based on clinical Amsel criteria for BV and reported symptoms by participant, i.e. discharge, vaginal odor, etc).
- Use of vaginal products in past 48 hours (i.e. douching, use of vaginal medications or suppositories).
Show all 23Show fewer
- History of chronic renal disease by verbal or documented history.
- Current use of probenecid.
- Nursing mothers.
- Colitis or coagulopathy as per patient self-report.
- Known allergy to cephalosporins, penicillin or macrolides by verbal or documented history.
- History of latex allergy.
- Use of systemic antibiotics (oral or intravenous), vaginal antibiotics, vaginal antifungal, or oral antifungal use within 30 days of study enrollment.
- Women who will require antibiotic treatment due to GC or CT in a sexual partner.
- Serious underlying conditions, including human immunodeficiency virus (HIV) or other primary or secondary immunosuppressive condition.
- Concomitant infection, which requires antimicrobial therapy (for example, urinary tract infection, sinusitis, skin and soft tissue infection, tooth abscess, etc.) or expected use of any antibiotic/antimicrobial therapy during the study.
- Menstruation at the time of screening visit. Women who are menstruating can be screened after cessation of bleeding.
- Active herpes outbreak at the time of enrollment determined by clinical observation.
- Suspected pregnancy or positive urine pregnancy test at screening or actively seeking pregnancy during study period.
- Any clinical adverse event, intercurrent illness, or other medical condition or situation as determined by the investigator that is present or occurs such that participation in the study would not be in the best interest of the participant.
- Previously enrolled in this study.
- Unable to follow the protocol (inc. inability to comply with the follow-up procedures).
- Failing to provide contact information.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, 35249-0001
University of Mississippi - Infectious Diseases
Jackson, Mississippi, 39216-4505
Louisiana Stte University - Health Sciences Center - Medicine
New Orleans, Louisiana, 70112-1349
Harbor UCLA Medical Center - OBGYN - General Gynecology and Women's Health
Torrance, California, 90502-2006
About this study
Official title: A Randomized Trial to Evaluate the Need for Empiric Therapy for Mucopurulent Cervicitis of Unknown Etiology
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.
Read the detailed description
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.
- Conditions
- Vaginitis Bacterial, Cervicitis
- Being tested
- Placebo, Azithromycin, Cefixime
- Keywords
- mucopurulent cervicitis, chlamydia, gonorrhea, women
- Medical subject headings
- Vaginosis, Bacterial, Uterine Cervicitis, Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Capsule will be filled with lactose and be identical in appearance to the capsule with the active ingredient.
AzithromycinDrug
Single dose will consist of 2 over-encapsulated capsules (500 mg each) administered orally.
CefiximeDrug
Single dose will consist of 1 over-encapsulated capsule (400 mg) administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo. Receives: Other: 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). Receives: Drug: Azithromycin; Drug: Cefixime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 2 - 2 months (Day 50-70).
Secondary outcomes (7)
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.
Measured: 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.
The proportion of participants experiencing one or more adverse events after randomization.
Measured: 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:
- 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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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:
- 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.
Measured: 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:
- 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.
Measured: At 2-3 weeks follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionDec 2011
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.
- Other trials for Vaginitis BacterialStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072136
- Sponsor's protocol ID
- 07-0082
- Status last verified
- Jan 2012
- First submitted
- 18 Feb 2010
- Last updated
- 24 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate the Need for Empiric Therapy for Mucopurulent Cervicitis of Unknown Etiology
- ClinicalTrials.gov ID
- NCT01072136
- Acronym / sponsor ID
- 07-0082
- Conditions
- Vaginitis Bacterial, Cervicitis
- Keywords
- mucopurulent cervicitis, chlamydia, gonorrhea, women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 87 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 25 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo. |
| Azithromycin/Cefixime | Experimental | Drug: Azithromycin, Drug: CefiximeA single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women greater than or equal to 18 years old in Sexually Transmitted Disease (STD) clinics or Family Planning clinics.
- Presence of cervical mucopus and/or easily induced cervical bleeding on pelvic exam via endocervical swab.
- Greater than or equal to 30 white blood cells (WBCs) per high power field in the cervical Gram stain. (Note: the cervical Gram stains will be sent to a central lab for review. The results will not be available at the time of enrollment. Subjects who do not meet this criterion will be withdrawn from the study at the time the results are available).
- Willingness to provide written informed consent
- Willing to abstain from sexual intercourse or use condoms during the entire study (approximately 2 months).
Key exclusion criteria (23 listed)
- Signs and symptoms of pelvic inflammatory disease, including cervical motion, uterine, or adnexal tenderness.
- History of pelvic inflammatory disease (PID), ectopic pregnancy or recurrent cervicitis (3 or more episodes in the prior year) or written documentation of recent cervicitis (within past 30 days).
- Gonorrhea or Chlamydia on nucleic acid amplification test (NAAT) at time of enrollment. (Participant testing positive for Neisseria gonorrhoeae (GC) or Chlamydia trachomatis (CT) on enrollment visit sample will be discontinued).
- Women with motile trichomonas on wet mount examination or positive trichomonas culture at time of enrollment.
- Women with symptomatic bacterial vaginosis (BV) (based on clinical Amsel criteria for BV and reported symptoms by participant, i.e. discharge, vaginal odor, etc).
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 |
|---|---|---|
| PlaceboCapsule will be filled with lactose and be identical in appearance to the capsule with the active ingredient. | Other | Placebo |
| AzithromycinSingle dose will consist of 2 over-encapsulated capsules (500 mg each) administered orally. | Drug | Azithromycin/Cefixime |
| CefiximeSingle dose will consist of 1 over-encapsulated capsule (400 mg) administered orally. | Drug | Azithromycin/Cefixime |
Primary outcome
Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC).
Time frame: Visit 2 - 2 months (Day 50-70).
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.
7 secondary outcomes
Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.
Time frame: 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.
Time frame: At 2-3 week and 2 month (Day 50-70) follow-up.
Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).
Time frame: At 2 month (Day 50-70) follow-up.
Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).
Time frame: At 2 month (Day 50-70) follow-up.
Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo.
Time frame: 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.
Time frame: 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.
Time frame: At 2-3 weeks follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Vaginitis Bacterial
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin and Cefixime in people with Vaginitis Bacterial and Cervicitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 23 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: stopped early, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Oct 2012). 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?
Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC). (time frame: Visit 2 - 2 months (Day 50-70).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2014.