MAIDEN: Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00683865

Collaborator

(none)

749

Enrollment

Locations

Arms

Duration (Months)

9.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Condition or Disease	Intervention/Treatment	Phase
Pelvic Inflammatory Disease	Drug: Ofloxacin Drug: Avelox (Moxifloxacin, BAY12-8039)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

749 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: Ofloxacin Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Experimental: Arm 2	Drug: Avelox (Moxifloxacin, BAY12-8039) Moxifloxacin 400 mg po od for 14 days

Arm

Intervention/Treatment

Active Comparator: Arm 1

Drug: Ofloxacin

Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days

Experimental: Arm 2

Drug: Avelox (Moxifloxacin, BAY12-8039)

Moxifloxacin 400 mg po od for 14 days

Outcome Measures

Primary Outcome Measures

Clinical response 5 to 24 days after the last dose of study medication [5 to 24 days after the last dose]

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 [visit 28 to 42 days after last dose]
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose [(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 [Over the entire trial period (overall)]
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up [Over the entire trial period (overall)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Hvidovre		Denmark	2650
2	Odense C		Denmark	DK-5000
3	Roskilde		Denmark	DK-4000
4	Helsinki		Finland	00029
5	Hämeenlinna		Finland	13530
6	Joensuu		Finland	80210
7	Kotka		Finland	48210
8	Antony Cedex		France	92166
9	Beaumont		France	63110
10	Bordeaux		France	33000
11	Brive-la-gaillarde		France	19100
12	Cenon		France	33150
13	Colombes Cedex		France	92701
14	Creteil Cedex		France	94010
15	Domont		France	95330
16	Lille		France	59037
17	Montauban		France	82000
18	Montpellier		France	34059
19	Muret		France	31600
20	Nancy Cedex		France	54045
21	Paris		France	75009
22	Paris		France	75020
23	Toulouse		France	31059
24	München	Bayern	Germany	80336
25	Rostock	Mecklenburg-Vorpommern	Germany	18057
26	Essen	Nordrhein-Westfalen	Germany	45257
27	Grevenbroich	Nordrhein-Westfalen	Germany	41515
28	Leverkusen	Nordrhein-Westfalen	Germany	51375
29	Wuppertal	Nordrhein-Westfalen	Germany	42103
30	Berlin		Germany	10117
31	Berlin		Germany	10249
32	Athens	Attica	Greece	115 21
33	Athens	Attica	Greece	11528
34	Dourouti-Ioannina	Ioannina	Greece	45500
35	Budapest		Hungary	1115
36	Budapest		Hungary	H-1085
37	Eger		Hungary	3301
38	Györ		Hungary	9024
39	Kecskemet		Hungary	6000
40	Pavia		Italy	27100
41	Perugia		Italy	06122
42	Trieste		Italy	34137
43	Klaipeda		Lithuania	92288
44	Vilnius		Lithuania	LT-04130
45	Vilnius		Lithuania	LT-2000
46	Vilnius		Lithuania	LT-2021
47	Bialystok		Poland	15-276
48	Krakow		Poland	30-501
49	Lodz		Poland	93-338
50	Lublin		Poland	20-090
51	Owock		Poland	05-400
52	Poznan		Poland	61-701
53	Warszawa		Poland	00-416
54	Warszawa		Poland	00-909
55	Moscow		Russian Federation	107076
56	Moscow		Russian Federation	117049
57	Moscow		Russian Federation	117997
58	Bloemfontein	Free State	South Africa	9300
59	Johannesburg	Gauteng	South Africa	1804
60	Johannesburg	Gauteng	South Africa	2132
61	Pretoria	Gauteng	South Africa	0001
62	Pretoria	Gauteng	South Africa
63	Durban	KwaZulu Natal	South Africa	4001
64	Cape Town	Western Cape	South Africa	7505
65	Cape Town	Western Cape	South Africa
66	Göteborg		Sweden	413 45
67	Linköping		Sweden	581 85
68	Lund		Sweden	221 85
69	Trollhättan		Sweden	461 85
70	Varberg		Sweden	432 81
71	Bristol	Avon	United Kingdom	BS2 8HW
72	London	Greater London	United Kingdom	SW10 9NH
73	London	Greater London	United Kingdom	SW17 0QT
74	London	Greater London	United Kingdom	WC1E 6AU
75	Southampton	Hampshire	United Kingdom	SO14 0YG
76	Nottingham	Nottinghamshire	United Kingdom	NG5 1PB
77	Birmingham	West Midlands	United Kingdom	B4 6DH