Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin. (MAIDEN)
Primary Purpose
Pelvic Inflammatory Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ofloxacin
Avelox (Moxifloxacin, BAY12-8039)
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Inflammatory Disease focused on measuring Antibiotic treatment, Pelvic infection, Interventional study, Female
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Clinical response 5 to 24 days after the last dose of study medication
Secondary Outcome Measures
Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose
Reduction from baseline in pain report at the different assessment visits
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00683865
Brief Title
Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.
Acronym
MAIDEN
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
Keywords
Antibiotic treatment, Pelvic infection, Interventional study, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
749 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ofloxacin
Intervention Description
Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Intervention Type
Drug
Intervention Name(s)
Avelox (Moxifloxacin, BAY12-8039)
Intervention Description
Moxifloxacin 400 mg po od for 14 days
Primary Outcome Measure Information:
Title
Clinical response 5 to 24 days after the last dose of study medication
Time Frame
5 to 24 days after the last dose
Secondary Outcome Measure Information:
Title
Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication
Time Frame
visit 28 to 42 days after last dose
Title
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose
Time Frame
(Day 4-7) and at follow-up 28 to 42 days after last dose
Title
Reduction from baseline in pain report at the different assessment visits
Time Frame
Over the entire trial period (overall)
Title
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up
Time Frame
Over the entire trial period (overall)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
City
Roskilde
ZIP/Postal Code
DK-4000
Country
Denmark
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
City
Hämeenlinna
ZIP/Postal Code
13530
Country
Finland
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
City
Kotka
ZIP/Postal Code
48210
Country
Finland
City
Antony Cedex
ZIP/Postal Code
92166
Country
France
City
Beaumont
ZIP/Postal Code
63110
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Brive-la-gaillarde
ZIP/Postal Code
19100
Country
France
City
Cenon
ZIP/Postal Code
33150
Country
France
City
Colombes Cedex
ZIP/Postal Code
92701
Country
France
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
City
Domont
ZIP/Postal Code
95330
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Montauban
ZIP/Postal Code
82000
Country
France
City
Montpellier
ZIP/Postal Code
34059
Country
France
City
Muret
ZIP/Postal Code
31600
Country
France
City
Nancy Cedex
ZIP/Postal Code
54045
Country
France
City
Paris
ZIP/Postal Code
75009
Country
France
City
Paris
ZIP/Postal Code
75020
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18057
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45257
Country
Germany
City
Grevenbroich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41515
Country
Germany
City
Leverkusen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51375
Country
Germany
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42103
Country
Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
10249
Country
Germany
City
Athens
State/Province
Attica
ZIP/Postal Code
115 21
Country
Greece
City
Athens
State/Province
Attica
ZIP/Postal Code
11528
Country
Greece
City
Dourouti-Ioannina
State/Province
Ioannina
ZIP/Postal Code
45500
Country
Greece
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1085
Country
Hungary
City
Eger
ZIP/Postal Code
3301
Country
Hungary
City
Györ
ZIP/Postal Code
9024
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Perugia
ZIP/Postal Code
06122
Country
Italy
City
Trieste
ZIP/Postal Code
34137
Country
Italy
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-2000
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-2021
Country
Lithuania
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Krakow
ZIP/Postal Code
30-501
Country
Poland
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Owock
ZIP/Postal Code
05-400
Country
Poland
City
Poznan
ZIP/Postal Code
61-701
Country
Poland
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1804
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2132
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
City
Pretoria
State/Province
Gauteng
Country
South Africa
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4001
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
City
Cape Town
State/Province
Western Cape
Country
South Africa
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
City
Trollhättan
ZIP/Postal Code
461 85
Country
Sweden
City
Varberg
ZIP/Postal Code
432 81
Country
Sweden
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
City
London
State/Province
Greater London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
City
London
State/Province
Greater London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
City
London
State/Province
Greater London
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6DH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.
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