Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01366651
Eligibility Criteria:
Inclusion Criteria:
* Patient is expected to require hospitalization for the entire open-label phase of the study.
* Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a "spinal tap") or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.
* Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV antibiotics.
* Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study.
Exclusion Criteria:
* Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.
* Any condition at screening that, in the opinion of the investigator, may interfere with the assessments of this study.
* Patients with substantially compromised renal (kidney) function: e.g., urine output is \<0.25cc/kg/hr within the 24 hours before screening.
* History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.
* Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.
* Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration.
* Patients concomitantly treated with probenecid or valproic acid (VPA).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Year
Study:
NCT01366651
Study Brief:
Protocol Section:
NCT01366651