Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01069900 · ClinicalTrials.gov registry record · Phase 3
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 458
- Enrollment target
NCT01069900: Completed Phase 3 study, sponsored by Bayer.
NCT01069900 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 458 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01069900, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 458 participants
- Enrollment target
Study 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.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Interventions
- DRUG Moxifloxacin (Avelox, BAY12-8039)
- DRUG Ertapenem
- DRUG Moxifloxacin placebo
- DRUG Amoxicillin/Clavulanate
- DRUG Ertapenem placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2010-07-21 |
| Est. Completion | 2015-01-21 |
| Phase | Phase 3 |
What the finished NCT01069900 record still lists
NCT01069900 is an interventional study that assigns participants to a tested intervention. The registered 458 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 5 interventions - of which Moxifloxacin (Avelox, BAY12-8039) is the first listed.
NCT01069900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01069900 about?
NCT01069900 is a clinical study titled "Moxifloxacin 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 int...
What is the current status of trial NCT01069900?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 458 participants. The study started on 2010-07-21. Estimated completion is 2015-01-21.
What interventions are being tested in trial NCT01069900?
The interventions under investigation include: Moxifloxacin (Avelox, BAY12-8039) (DRUG), Ertapenem (DRUG), Moxifloxacin placebo (DRUG), Amoxicillin/Clavulanate (DRUG), Ertapenem placebo (DRUG).
Who is sponsoring clinical trial NCT01069900?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01069900's enrollment target sits among peer trials
458 827th of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05856942 · 458 participants · NA
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
- NCT06201676 · 458 participants · Phase 4
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
- NCT04452825 · 459 participants · NA
A New Psychotherapy Intervention for Older Cancer Patients
- NCT02977780 · 460 participants · Phase 2
INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI