Pelvic Inflammatory DiseasePhase 4NCT01799356
Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
A Phase 4 study testing Moxifloxacin, Ofloxacin and Metronidazole in people with Pelvic Inflammatory Disease, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 4 sites in Turkey (Türkiye).
Trial summary
We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Moxifloxacin, Ofloxacin and Metronidazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,303 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Jun 2010to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women diagnosed uncomplicated PID
- Patients age are between 14 with 45
- Pelvic tenderness and vaginal discharge
Who cannot join
- Urinary Tract Enfections
- Tubo-ovarian abscess and complicated PID
- Hıstory of antibiotics treatment
- Other pelvic pain causes
- Endometriosis
- Delivery,abortion and surgery within last months
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
T.C.S.B. Kanuni Sultan Suleyman Training Hospital
Istanbul, Kucukcekmece, 34280
T.C.S.B Mardin Women and Children Hospital
Mardin, Mardin, 47000
T.C.S.B. İstanbul Training Research Hospital
Samatya, Fatih, 34180
T.C.S.B. Şişli Etfal Training Research Hospital
Şişli, Şişli, 34150
About this study
We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Moxifloxacin, Ofloxacin, Metronidazole
- Keywords
- Treatment, moksifloksasin
- 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.
MoxifloxacinDrug
Also called new generetaion flouroquinolon antibiotics
daily 400 mg moksifloksasin
OfloxacinDrug
Also called floroquinolon antibiotics
daily 800 mg oflaksasin plus 1000 mg metronidazol treatment
MetronidazoleDrug
Also called anaerobic antibiotics
daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID
| Study group | Role | What they receive |
|---|---|---|
| moxifloxacin Group | Active comparator | Treatment at uPID with moxifloxacin Receives: Drug: Moxifloxacin |
| Ofloxacin Group | Placebo comparator | Treatment at uPID with Ofloxacin plus metronidazole Receives: Drug: Ofloxacin; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically cure
Measured: 21 Days
Secondary outcomes (1)
Microbiological cure
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Investigators
- Kemal Gungorduk, md, Study chair, T.C.S.B. Kanıni Sultan Suleyman Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799356
- Sponsor's protocol ID
- Asicioglu03
- Other IDs
- treatment, treatment uPID
- Status last verified
- Aug 2013
- First submitted
- 16 Feb 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
Publications
Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.
PubMed 20716255Boothby M, Page J, Pryor R, Ross JD. A comparison of treatment outcomes for moxifloxacin versus ofloxacin/metronidazole for first-line treatment of uncomplicated non-gonococcal pelvic inflammatory disease. Int J STD AIDS. 2010 Mar;21(3):195-7. doi: 10.1258/ijsa.2009.009374.
PubMed 20215625Savaris RF, Fuhrich DG, Maissiat J, Duarte RV, Ross J. Antibiotic therapy for pelvic inflammatory disease. Cochrane Database Syst Rev. 2020 Aug 20;8(8):CD010285. doi: 10.1002/14651858.CD010285.pub3.
PubMed 32820536
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT01799356
- Acronym / sponsor ID
- Asicioglu03
- Conditions
- Pelvic Inflammatory Disease
- Keywords
- Treatment, moksifloksasin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,303 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moxifloxacin Group | Active comparator | Drug: MoxifloxacinTreatment at uPID with moxifloxacin |
| Ofloxacin Group | Placebo comparator | Drug: Ofloxacin, Drug: MetronidazoleTreatment at uPID with Ofloxacin plus metronidazole |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women diagnosed uncomplicated PID
- Patients age are between 14 with 45
- Pelvic tenderness and vaginal discharge
Key exclusion criteria (6 listed)
- Urinary Tract Enfections
- Tubo-ovarian abscess and complicated PID
- Hıstory of antibiotics treatment
- Other pelvic pain causes
- Endometriosis
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 |
|---|---|---|
| MoxifloxacinAlso: new generetaion flouroquinolon antibioticsdaily 400 mg moksifloksasin | Drug | moxifloxacin Group |
| OfloxacinAlso: floroquinolon antibioticsdaily 800 mg oflaksasin plus 1000 mg metronidazol treatment | Drug | Ofloxacin Group |
| MetronidazoleAlso: anaerobic antibioticsdaily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID | Drug | Ofloxacin Group |
Primary outcome
Clinically cure
Time frame: 21 Days
1 secondary outcome
Microbiological cure
Time frame: 21 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Results publication: PubMed 20716255Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.
- Results publication: PubMed 20215625Boothby M, Page J, Pryor R, Ross JD. A comparison of treatment outcomes for moxifloxacin versus ofloxacin/metronidazole for first-line treatment of uncomplicated non-gonococcal pelvic inflammatory disease. Int J STD AIDS. 2010 Mar;21(3):195-7. doi: 10.1258/ijsa.2009.009374.
- Derived from this study: PubMed 32820536Savaris RF, Fuhrich DG, Maissiat J, Duarte RV, Ross J. Antibiotic therapy for pelvic inflammatory disease. Cochrane Database Syst Rev. 2020 Aug 20;8(8):CD010285. doi: 10.1002/14651858.CD010285.pub3.
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.
Kemal Gungorduk, md study chair
T.C.S.B. Kanıni Sultan Suleyman Training Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxifloxacin, Ofloxacin and Metronidazole in people with Pelvic Inflammatory Disease, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 4 sites in Turkey (Türkiye).
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 3 inclusion and 6 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 28 Aug 2013. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinically cure (time frame: 21 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 NCT01799356, which also lists 3 linked publications.
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 28 Aug 2013.