Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

NCT ID: NCT01069900

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-21
• Study Completion Date: 2015-01-21

Brief Summary

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.

Conditions

Intraabdominal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Moxifloxacin (Avelox, BAY12-8039)

Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.

Group Type: EXPERIMENTAL

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type: DRUG

For subjects 12 to less than (\<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to \< 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to \< 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided.

Ertapenem placebo

Intervention Type: DRUG

Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.

Amoxicillin/Clavulanate placebo

Intervention Type: DRUG

Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.

Comparator Ertapenem

Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Group Type: ACTIVE_COMPARATOR

Ertapenem

Intervention Type: DRUG

For subjects 13 to \<18 years of age, the dosage of ertapenem was 1 gram (g) OD. For subjects 3 months to \< 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day.

Amoxicillin/Clavulanate

Intervention Type: DRUG

Subjects 2 years to \< 18 years of age who were switched from IV to PO therapy receive amoxicillin/clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h). The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).

Moxifloxacin placebo

Intervention Type: DRUG

Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets.

Interventions

Moxifloxacin (Avelox, BAY12-8039)

For subjects 12 to less than (\<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to \< 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to \< 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided.

Intervention Type: DRUG

Ertapenem

For subjects 13 to \<18 years of age, the dosage of ertapenem was 1 gram (g) OD. For subjects 3 months to \< 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day.

Intervention Type: DRUG

Amoxicillin/Clavulanate

Subjects 2 years to \< 18 years of age who were switched from IV to PO therapy receive amoxicillin/clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h). The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).

Intervention Type: DRUG

Moxifloxacin placebo

Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets.

Intervention Type: DRUG

Ertapenem placebo

Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.

Intervention Type: DRUG

Amoxicillin/Clavulanate placebo

Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

San Diego, California, United States

Springfield, Massachusetts, United States

Hospital de Agudos "Dr. Carlos Bocalandro"

Tres de Febrero, Buenos Aires, Argentina

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Stara Zagora, , Bulgaria

Calgary, Alberta, Canada

Hamilton, Ontario, Canada

Montreal, Quebec, Canada

Santiago, , Chile

Olomouc, , Czechia

Prague, , Czechia

Stuttgart, Baden-Wurttemberg, Germany

Regensburg, Bavaria, Germany

Wuppertal, North Rhine-Westphalia, Germany

Athens, , Greece

Budapest, , Hungary

Győr, , Hungary

Daugavpils, , Latvia

Rēzekne, , Latvia

Riga, , Latvia

Kaunas, , Lithuania

Vilnius, , Lithuania

Guadalajara, Jalisco, Mexico

México, D.F., Mexico City, Mexico

Ecatepec de Morelos, State of Mexico, Mexico

Cusco, , Peru

Lima, , Peru

Lima, , Peru

Iași, , Romania

Timișoara, , Romania

Smolensk, , Russia

Vladikavkaz, , Russia

Dnipropetrovsk, , Ukraine

Ivano-Frankivsk, , Ukraine

Lviv, , Ukraine

Simferopol, , Ukraine

Countries

United States; Argentina; Bulgaria; Canada; Chile; Czechia; Germany; Greece; Hungary; Latvia; Lithuania; Mexico; Peru; Romania; Russia; Ukraine

References

Wirth S, Emil SGS, Engelis A, Digtyar V, Criollo M, DiCasoli C, Stass H, Willmann S, Nkulikiyinka R, Grossmann U; MOXIPEDIA Study Group. Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study. Pediatr Infect Dis J. 2018 Aug;37(8):e207-e213. doi: 10.1097/INF.0000000000001910.

Reference Type: RESULT

PMID: 29356761 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

1962 (Avelox pediatrics)

Identifier Type: OTHER

Identifier Source: secondary_id

2009-015578-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11643

Identifier Type: -

Identifier Source: org_study_id