Clinical trial NCT00683865: Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.
Official title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Inflammatory Disease
Keywords: Antibiotic treatment
Pelvic infection
Interventional study
Female
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 749
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
* Adnexal tenderness on bimanual vaginal examination,
* Temperature \> 38.0°C; - Elevated C-reactive protein value (CRP);
* Signed PIC/IC

Exclusion Criteria:

* Pregnancy
* Abnormal lab values

Primary outcomes:
measure: Clinical response 5 to 24 days after the last dose of study medication
timeFrame: 5 to 24 days after the last dose
Secondary outcomes:
measure: Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication
timeFrame: visit 28 to 42 days after last dose
measure: Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose
timeFrame: (Day 4-7) and at follow-up 28 to 42 days after last dose
measure: Reduction from baseline in pain report at the different assessment visits
timeFrame: Over the entire trial period (overall)
measure: Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up
timeFrame: Over the entire trial period (overall)
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
city: Odense C
country: Denmark
city: Roskilde
country: Denmark
city: Helsinki
country: Finland
city: Hämeenlinna
country: Finland
city: Joensuu
country: Finland
city: Kotka
country: Finland
city: Antony Cedex
country: France
city: Beaumont
country: France
city: Bordeaux
country: France
city: Brive-la-gaillarde
country: France
city: Cenon
country: France
city: Colombes Cedex
country: France
city: Creteil Cedex
country: France
city: Domont
country: France
city: Lille
country: France
city: Montauban
country: France
city: Montpellier
country: France
city: Muret
country: France
city: Nancy Cedex
country: France
city: Paris
country: France
city: Paris
country: France
city: Toulouse
country: France
city: München
country: Germany
state: Bayern
city: Rostock
country: Germany
state: Mecklenburg-Vorpommern
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Grevenbroich
country: Germany
state: Nordrhein-Westfalen
city: Leverkusen
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Athens
country: Greece
state: Attica
city: Athens
country: Greece
state: Attica
city: Dourouti-Ioannina
country: Greece
state: Ioannina
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Eger
country: Hungary
city: Györ
country: Hungary
city: Kecskemet
country: Hungary
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Trieste
country: Italy
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Owock
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Bloemfontein
country: South Africa
state: Free State
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Durban
country: South Africa
state: KwaZulu Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Göteborg
country: Sweden
city: Linköping
country: Sweden
city: Lund
country: Sweden
city: Trollhättan
country: Sweden
city: Varberg
country: Sweden
city: Bristol
country: United Kingdom
state: Avon
city: London
country: United Kingdom
state: Greater London
city: London
country: United Kingdom
state: Greater London
city: London
country: United Kingdom
state: Greater London
city: Southampton
country: United Kingdom
state: Hampshire
city: Nottingham
country: United Kingdom
state: Nottinghamshire
city: Birmingham
country: United Kingdom
state: West Midlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: