Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
Primary Purpose
Pelvic Inflammatory Disease
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Moxifloxacin
Ofloxacin
Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Inflammatory Disease focused on measuring Treatment, moksifloksasin
Eligibility Criteria
Inclusion Criteria:
- Women diagnosed uncomplicated PID
- Patients age are between 14 with 45
- Pelvic tenderness and vaginal discharge
Exclusion Criteria:
- 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
Sites / Locations
- T.C.S.B. İstanbul Training Research Hospital
- T.C.S.B. Kanuni Sultan Suleyman Training Hospital
- T.C.S.B Mardin Women and Children Hospital
- T.C.S.B. Şişli Etfal Training Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
moxifloxacin Group
Ofloxacin Group
Arm Description
Treatment at uPID with moxifloxacin
Treatment at uPID with Ofloxacin plus metronidazole
Outcomes
Primary Outcome Measures
Clinically cure
Secondary Outcome Measures
Microbiological cure
Full Information
NCT ID
NCT01799356
First Posted
February 16, 2013
Last Updated
August 27, 2013
Sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01799356
Brief Title
Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
Keywords
Treatment, moksifloksasin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
moxifloxacin Group
Arm Type
Active Comparator
Arm Description
Treatment at uPID with moxifloxacin
Arm Title
Ofloxacin Group
Arm Type
Placebo Comparator
Arm Description
Treatment at uPID with Ofloxacin plus metronidazole
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
new generetaion flouroquinolon antibiotics
Intervention Description
daily 400 mg moksifloksasin
Intervention Type
Drug
Intervention Name(s)
Ofloxacin
Other Intervention Name(s)
floroquinolon antibiotics
Intervention Description
daily 800 mg oflaksasin plus 1000 mg metronidazol treatment
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
anaerobic antibiotics
Intervention Description
daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID
Primary Outcome Measure Information:
Title
Clinically cure
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
Microbiological cure
Time Frame
21 Days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women diagnosed uncomplicated PID
Patients age are between 14 with 45
Pelvic tenderness and vaginal discharge
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemal Gungorduk, md
Organizational Affiliation
T.C.S.B. Kanıni Sultan Suleyman Training Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
T.C.S.B. İstanbul Training Research Hospital
City
Samatya
State/Province
Fatih
ZIP/Postal Code
34180
Country
Turkey
Facility Name
T.C.S.B. Kanuni Sultan Suleyman Training Hospital
City
İstanbul
State/Province
Kucukcekmece
ZIP/Postal Code
34280
Country
Turkey
Facility Name
T.C.S.B Mardin Women and Children Hospital
City
Mardin
ZIP/Postal Code
47000
Country
Turkey
Facility Name
T.C.S.B. Şişli Etfal Training Research Hospital
City
Şişli
ZIP/Postal Code
34150
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
20716255
Citation
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.
Results Reference
result
PubMed Identifier
20215625
Citation
Boothby 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.
Results Reference
result
PubMed Identifier
32820536
Citation
Savaris 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.
Results Reference
derived
Learn more about this trial
Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
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