Trial Condition(s):

Intraabdominal Infections

Moxifloxacin in pediatric subjects with complicated intra-abdominal infection (MOXIPEDIA)

Bayer Identifier:

11643

ClinicalTrials.gov Identifier:

NCT01069900

EudraCT Number:

2009-015578-37

Study Completed

Trial Purpose

The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.

Inclusion Criteria
- Hospitalized males or females 3 months to 17 years of age
 - Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations
 - Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO
 - If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included.
 - Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following:
 -- Gross peritoneal inflammation with purulent exudate within the abdominal cavity
 -- Intra-abdominal abscess
 -- Macroscopic intestinal perforation with diffuse peritonitis
OR
 - Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following:
 -- Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain)
 -- Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
 -- Fever
 -- Leukocytosis
 - The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage.
Exclusion Criteria
- Presumed spontaneous bacterial peritonitis
 - All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
 - Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination
 - Infections originating from the female genital tract
 - Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm3) may be enrolled.
 - Congenital or documented acquired QT prolongation
 - Receiving concomitant treatment with QT prolonging drugs
 - History of tendon disease/disorder related to quinolone treatment
 - Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs
 - Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
 - History of myasthenia gravis

Trial Summary

Enrollment Goal
458
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wuppertal, Germany, 42283

Status
Completed
 
Locations

Investigative Site

Stuttgart, Germany, 70176

Status
Completed
 
Locations

Investigative Site

Regensburg, Germany, 93049

Status
Completed
 
Locations

Investigative Site

Springfield, United States, 01199

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H3H 1P3

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8N 3Z5

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T3B 6A8

Status
Completed
 
Locations

Investigative Site

México, D.F., Mexico, 04530

Status
Completed
 
Locations

Investigative Site

Olomouc, Czech Republic, 77520

Status
Completed
 
Locations

Investigative Site

Sofia, Bulgaria, 1606

Status
Completed
 
Locations

Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Investigative Site

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Investigative Site

Pleven, Bulgaria, 5800

Status
Completed
 
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Investigative Site

Gyor, Hungary, 9024

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1086

Status
Completed
 
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Investigative Site

Ecatepec de Morelos, Mexico, 55020

Status
Completed
 
Locations

Investigative Site

Prague, Czech Republic, 150 06

Status
Completed
 
Locations

Investigative Site

Ruse, Bulgaria, 7002

Status
Completed
 
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Investigative Site

Vladikavkaz, Russia, 362019

Status
Completed
 
Locations

Investigative Site

Kaunas, Lithuania, LT-50009

Status
Completed
 
Locations

Investigative Site

Lima, Peru, LIMA 1

Status
Completed
 
Locations

Investigative Site

Cusco, Peru

Status
Completed
 
Locations

Investigative Site

Smolensk, Russia, 214019

Status
Completed
 
Locations

Investigative Site

Simferopol, Ukraine, 95034

Status
Completed
 
Locations

Investigative Site

Ivano-Frankovsk, Ukraine, 76006

Status
Completed
 
Locations

Investigative Site

Lviv, Ukraine, 79004

Status
Completed
 
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Investigative Site

Vilnius, Lithuania, LT-08661

Status
Completed
 
Locations

Investigative Site

Lima, Peru

Status
Completed
 
Locations

Investigative Site

Iasi, Romania, 700309

Status
Completed
 
Locations

Investigative Site

Timisoara, Romania, 300011

Status
Completed
 
Locations

Investigative Site

Daugavpils, Latvia, LV-5417

Status
Completed
 
Locations

Investigative Site

Riga, Latvia, LV1004

Status
Completed
 
Locations

Investigative Site

Rezekne, Latvia, LV-4601

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92123

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico, C.P. 44280

Status
Completed
 
Locations

Hospital de Agudos "Dr. Carlos Bocalandro"

Tres de Febrero, Argentina, 1657

Status
Terminated
 
Locations

Investigative Site

Santiago, Chile

Status
Completed
 
Locations

Investigative Site

Athens, Greece, 115 27

Status
Completed
 
Locations

Investigative Site

Dnipropetrovsk, Ukraine, 49100

Status
Completed
 

Trial Design