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Not yet recruiting NCT07306234

Doxycycline vs. Macrolide for MRMP (DOMINO)

Phase IV Interventional Mycoplasma Pneumoniae Mycoplasma Pneumoniae Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxycycline, Azithromycin.
Who it may be relevant to
Registry conditions: Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia. Basic parameters: 3 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Doxycycline Versus Macrolides for Mycoplasma Pneumoniae Infection in Children (DOMINO): A Protocol for a Multicenter, Randomized, Open-Label, Superiority Trial

Overview

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

  • Drug Doxycycline
    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.
  • Drug Azithromycin
    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. Consis

Primary outcome measures

  • Defervescence rate [Time frame: 72 hours]
Secondary outcome measures (7)
  • Hospitalization Rate [Time frame: Up to 30 days]
  • Length of Hospital Stay [Time frame: Up to 30 days]
  • Hospital Readmission Rate [Time frame: Up to 30 days]
  • Treatment Failure Rate at Day 7 [Time frame: 7 days]
  • Time to Resolution of Respiratory Symptoms [Time frame: Up to 30 days]
  • Time to Radiological Resolution of Infiltrates [Time frame: Up to 30 days]
  • Incidence of Tooth Discoloration in Children Under 8 Years [Time frame: Day 28]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 14 centers
  • Department of Pediatrics, Pusan National University School of Medicine, Pusan National Uni — Busan
  • Department of Pediatrics, Gyeongsang National University College of Medicine, Gyeongsang N — Changwon
  • Department of Pediatrics, Chosun University College of Medicine, Chosun University Hospita — Gwangju
  • Department of Pediatrics, Jeju National University School of Medicine, Jeju National Unive — Jeju City
  • Department of Pediatrics, CHA University School of Medicine, CHA Bundang Medical Center, S — Seongnam
  • Department of Pediatrics, Seoul National University College of Medicine, Seoul National Un — Seongnam
  • Department of Pediatrics, College of Medicine, The Catholic University of Korea, Eunpyeong — Seoul
  • Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul St. — Seoul
  • … and 6 more centers

Publications

  • Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, Krause PJ, Bakken JS, Strle F, Stanek G, Bockenstedt L, Fish D, Dumler JS, Nadelman RB. The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006 Nov 1;43(9):1089-134. PMID 17029130
  • Cummings MM. Copyright and reproduction. Bull Med Libr Assoc. 1973 Jul;61(3):344-5. No abstract available. PMID 4725345
  • Kang DH, Lee JY, Chung JH, Cho JM, Lee SH, Park J, Kim TH, Yoo TK, Lee SW. Comparison of efficacy for erectile function and lower urinary tract symptoms of tadalafil 20 mg on-demand and 5 mg once daily in patients with erectile dysfunction. Int J Clin Pract. 2012 Aug;66(8):813-820. doi: 10.1111/j.1742-1241.2012.02946.x. PMID 22805273
  • Xue H, Xu H, Song X, Chen M, Wang X, Ji M, Wang M. Porous Frustrated Lewis Pairs Catalyst Constructed on Defective Zirconium-Based Metal-Organic Frameworks for Hydrogenation Reactions with H2. Inorg Chem. 2024 Aug 26;63(34):16011-16017. doi: 10.1021/acs.inorgchem.4c02470. Epub 2024 Aug 15. PMID 39145892
  • Guo T, Zamuner F, Ting S, Chen L, Rooper L, Tamayo P, Fakhry C, Gaykalova D, Mehra R. Clinical and genomic characterization of chemoradiation-resistant HPV-positive oropharyngeal squamous cell carcinoma. Front Oncol. 2024 Mar 5;14:1336577. doi: 10.3389/fonc.2024.1336577. eCollection 2024. PMID 38505587
  • Forde E, Humphreys H, Greene CM, Fitzgerald-Hughes D, Devocelle M. Potential of host defense peptide prodrugs as neutrophil elastase-dependent anti-infective agents for cystic fibrosis. Antimicrob Agents Chemother. 2014;58(2):978-85. doi: 10.1128/AAC.01167-13. Epub 2013 Nov 25. PMID 24277028
  • Liu Y. [Lay further emphasis on the cosmetic repair of deep burn wounds in extraordinary regions or caused by uncommon agents]. Zhonghua Shao Shang Za Zhi. 2014 Oct;30(5):389-91. Chinese. PMID 25572886
  • Jiao R, Xue B, Zhang M. A Multiform Optimization Framework for Constrained Multiobjective Optimization. IEEE Trans Cybern. 2023 Aug;53(8):5165-5177. doi: 10.1109/TCYB.2022.3178132. Epub 2023 Jul 18. PMID 35687640

Identifiers

NCT: NCT07306234 · DOMINO · KNIH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗