Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia
Conditions
Keywords
Mycoplasma pneumoniae, Macrolide resistance, Children
Brief summary
The goal of this clinical trial is to learn if doxycycline works to treat pneumonia in children. It focuses on children with Mycoplasma pneumoniae infection that may not respond to standard medicines. The main questions it aims to answer are: * Does doxycycline stop fevers faster than azithromycin? * Is doxycycline safe for children, specifically regarding tooth color changes? Researchers will compare doxycycline to azithromycin to see if doxycycline works better to treat this type of pneumonia. Participants will: * Take either doxycycline or azithromycin by mouth for 7 to 14 days. * Check their body temperature to see when their fever goes away. * Visit the hospital to check for any medical problems. * Have their teeth checked for color changes 28 days after starting the medicine.
Interventions
DRUGDoxycycline
Intervention Group (Doxycycline): Participants will receive oral doxycycline (4 mg/kg/day divided into 2 doses for weight ≤45 kg; 100 mg BID for weight \>45 kg). The standard treatment duration is 7 days, which may be extended up to 14 days based on clinical response.
DRUGAzithromycin
Control Group (Azithromycin): Participants will receive oral azithromycin according to the standard 5-day regimen (10 mg/kg on Day 1, followed by 5 mg/kg on Days 2-5). Rescue Therapy Protocol: To ensure patient safety, a standardized rescue therapy protocol is implemented. Participants in the Control group who fail to demonstrate clinical improvement at the 48-72 hour assessment-defined as persistent fever (≥38.0°C) or clinical deterioration-will be immediately switched to doxycycline. Consistent with the intention-to-treat principle, these cases will be classified as treatment failures for the primary efficacy analysis.
Sponsors
Korea Society of Pediatric Infectious Diseases
Korea National Institute of Health
Korea Disease Control and Prevention Agency
DT&CRO
Young June Choe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defervescence rate | 72 hours | Defervescence rate at 72 hours. Defervescence is defined as the maintenance of body temperature below 38.0°C for at least 24 consecutive hours without antipyretics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Up to 30 days | The duration of hospitalization from admission to discharge. |
| Hospital Readmission Rate | Up to 30 days | Percentage of participants readmitted to the hospital after initial discharge due to worsening of pneumonia. |
| Treatment Failure Rate at Day 7 | 7 days | Treatment failure is defined as the occurrence of any of the following: need for rescue therapy (switching to doxycycline for the control group), addition of other antibiotics or systemic steroids, or clinical deterioration requiring intensive care unit (ICU) admission. |
| Hospitalization Rate | Up to 30 days | Percentage of participants requiring hospitalization due to the progression of pneumonia or complications. |
| Time to Radiological Resolution of Infiltrates | Up to 30 days | Time to resolution of pulmonary infiltrates as confirmed by chest radiography follow-up. |
| Incidence of Tooth Discoloration in Children Under 8 Years | Day 28 | Assessment of visible tooth discoloration evaluated by visual inspection. |
| Time to Resolution of Respiratory Symptoms | Up to 30 days | Time to resolution of respiratory symptoms (cough, dyspnea) assessed using a 4-point Likert scale. Resolution is defined as the point at which the symptom score reaches 0 (none) or 1 (mild) and is maintained |
Countries
South Korea
Contacts
Primary ContactYoung June Choe, MD
Outcome results
None listed