Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:4/17/2018
Start Date:July 21, 2010
End Date:January 21, 2015

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A Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, Oral) Moxifloxacin Versus Comparator in Pediatric Subjects With Complicated Intra-abdominal Infection

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
We found this trial at
3
sites
Springfield, Massachusetts 01199
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Springfield, MA
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San Diego, CA
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Tres De Febrero, Buenos Aires
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Tres De Febrero,
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