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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07306234
Eligibility Criteria:
Inclusion Criteria:
* Age: 3 to 17 years at the time of enrollment.
* Diagnosis: Clinically diagnosed CAP characterized by respiratory symptoms (e.g., fever, cough, auscultatory findings) and chest X-ray confirming pulmonary infiltrates.
* Pathogen: Confirmed MP M. pneumoniae infection via PCR OR strongly suspected infection based on clinical features and epidemiological grounds (e.g., outbreaks among classmates, poor response to prior non-macrolide antibiotics).
* Resistance: Suspected macrolide-resistant M. pneumoniae (MRMP) infection (e.g., during a reported local epidemic of MRMP).
* Timing: Ability to register and initiate the study drug within 72 hours of symptom onset.
Exclusion Criteria:
* Prior use of tetracyclines, macrolides, or quinolones for the current illness.
* Complicated pneumonia (e.g., necrosis, empyema, lung abscess) or severe pneumonia requiring immediate intensive care or exhibiting hypoxia (SpO₂ \<90%).
* Hypersensitivity or contraindications to macrolides or tetracyclines.
* Severe immunocompromised state or severe underlying lung disease.
* Severe hepatic impairment (AST/ALT \>3x upper limits) or severe renal impairment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT07306234
Study Brief:
Protocol Section:
NCT07306234