NCT01799356

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,303

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

2.8 years

First QC Date

February 16, 2013

Last Update Submit

August 27, 2013

Conditions

Pelvic Inflammatory Disease

Keywords

Treatment, moksifloksasin

Outcome Measures

Primary Outcomes (1)

  • Clinically cure

    21 Days

Secondary Outcomes (1)

  • Microbiological cure

    21 Days

Study Arms (2)

moxifloxacin Group

ACTIVE COMPARATOR

Treatment at uPID with moxifloxacin

Drug: Moxifloxacin

Ofloxacin Group

PLACEBO COMPARATOR

Treatment at uPID with Ofloxacin plus metronidazole

Drug: OfloxacinDrug: Metronidazole

Interventions

MoxifloxacinDRUG

daily 400 mg moksifloksasin

Also known as: new generetaion flouroquinolon antibiotics
moxifloxacin Group
OfloxacinDRUG

daily 800 mg oflaksasin plus 1000 mg metronidazol treatment

Also known as: floroquinolon antibiotics
Ofloxacin Group
MetronidazoleDRUG

daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID

Also known as: anaerobic antibiotics
Ofloxacin Group

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women diagnosed uncomplicated PID
  • Patients age are between 14 with 45
  • Pelvic tenderness and vaginal discharge

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

T.C.S.B. İstanbul Training Research Hospital

Samatya, Fatih, 34180, Turkey (Türkiye)

Location

T.C.S.B. Kanuni Sultan Suleyman Training Hospital

Istanbul, Kucukcekmece, 34280, Turkey (Türkiye)

Location

T.C.S.B Mardin Women and Children Hospital

Mardin, Mardin, 47000, Turkey (Türkiye)

Location

T.C.S.B. Şişli Etfal Training Research Hospital

Şişli, Şişli, 34150, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 20716255RESULT

  • 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.

    PMID: 20215625RESULT

  • 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.

    PMID: 32820536DERIVED

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Interventions

MoxifloxacinOfloxacinMetronidazole

Condition Hierarchy (Ancestors)

Pelvic InfectionInfectionsAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Kemal Gungorduk, md

    T.C.S.B. Kanıni Sultan Suleyman Training Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Istanbul Sisli Etfal Training Research Hospital

Study Record Dates

First Submitted

February 16, 2013

First Posted

February 26, 2013

Study Start

June 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

TU(4)