Health TrialsbyHealthPanel

Doxycycline vs. Macrolide for MRMP (DOMINO)

ConditionsMycoplasma PneumoniaeMycoplasma Pneumoniae Pneumonia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-17
SponsorYoung June Choe

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxycycline

    Drug

    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.

  • Azithromycin

    Drug

    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.

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Intervention Group (Doxycycline)Experimental treatment 1 intervention
Group B: Control Group (Azithromycin)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Defervescence rate

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.

Time frame
72 hours

Secondary outcomes

1

Hospitalization Rate

Percentage of participants requiring hospitalization due to the progression of pneumonia or complications.

Time frame
Up to 30 days
2

Length of Hospital Stay

The duration of hospitalization from admission to discharge.

Time frame
Up to 30 days
3

Hospital Readmission Rate

Percentage of participants readmitted to the hospital after initial discharge due to worsening of pneumonia.

Time frame
Up to 30 days
4

Treatment Failure Rate at Day 7

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.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Young June Choe

Lead sponsor

Korea University Anam Hospital

Sponsor institution

Korea Society of Pediatric Infectious Diseases

Collaborator

National Institute of Health, Korea

Collaborator

Korea Disease Control and Prevention Agency

Collaborator

DT&CRO

Collaborator

Source ClinicalTrials.gov

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