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:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT03757234
Eligibility Criteria:
Inclusion Criteria:
* Female participants, age 18-65 years who have signed the informed consent form
* Must have a qualifying acute pyelonephritis
* Participants must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
* Must be able to comply with all of the requirements of the study
Exclusion Criteria:
* Males
* Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
* Infections that require antibacterial treatment for greater than 14 days
* Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
* Evidence of significant immunological disease
* Evidence of liver impairment or disease
* Evidence of unstable cardiac disease
* Severe renal disease or requirement for dialysis
* Evidence of septic shock
* Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
* Has received an investigational drug within the past 30 days
* Participants who are pregnant or nursing
* Unable or unwilling to comply with the protocol requirements
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03757234
Study Brief:
Protocol Section:
NCT03757234