Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials

NCT ID: NCT01799356

Last Updated: 2013-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Pelvic Inflammatory Disease

Keywords

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Treatment, moksifloksasin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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moxifloxacin Group

Treatment at uPID with moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

daily 400 mg moksifloksasin

Ofloxacin Group

Treatment at uPID with Ofloxacin plus metronidazole

Group Type PLACEBO_COMPARATOR

Ofloxacin

Intervention Type DRUG

daily 800 mg oflaksasin plus 1000 mg metronidazol treatment

Metronidazole

Intervention Type DRUG

daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID

Interventions

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Moxifloxacin

daily 400 mg moksifloksasin

Intervention Type DRUG

Ofloxacin

daily 800 mg oflaksasin plus 1000 mg metronidazol treatment

Intervention Type DRUG

Metronidazole

daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID

Intervention Type DRUG

Other Intervention Names

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new generetaion flouroquinolon antibiotics floroquinolon antibiotics anaerobic antibiotics

Eligibility Criteria

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Inclusion Criteria

1. Women diagnosed uncomplicated PID
2. Patients age are between 14 with 45
3. Pelvic tenderness and vaginal discharge

Exclusion Criteria

1. Urinary Tract Enfections
2. Tubo-ovarian abscess and complicated PID
3. Hıstory of antibiotics treatment
4. Other pelvic pain causes
5. Endometriosis
6. Delivery,abortion and surgery within last months
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Bakirkoy Maternity and Children Diseases Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Osman Aşıcıoğlu

Istanbul Sisli Etfal Training Research Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kemal Gungorduk, md

Role: STUDY_CHAIR

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

Locations

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

Samatya, Fatih, Turkey (Türkiye)

Site Status

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

Istanbul, Kucukcekmece, Turkey (Türkiye)

Site Status

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

Mardin, Mardin, Turkey (Türkiye)

Site Status

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

Şişli, Şişli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 20716255 (View on PubMed)

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.

Reference Type RESULT
PMID: 20215625 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32820536 (View on PubMed)

Other Identifiers

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treatment

Identifier Type: OTHER

Identifier Source: secondary_id

treatment uPID

Identifier Type: OTHER

Identifier Source: secondary_id

Asicioglu03

Identifier Type: -

Identifier Source: org_study_id