Doxycycline vs. Macrolide for MRMP (DOMINO)

NCT07306234 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: DOMINOKNIH
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 14

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.

Conditions

Mycoplasma Pneumoniae Pneumonia; Mycoplasma Pneumoniae

Keywords

Mycoplasma pneumoniae; Macrolide resistance; Children

Outcome Measures

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.

  72 hours

Secondary Outcomes (7)

• Hospitalization Rate

  Up to 30 days

• Length of Hospital Stay

  Up to 30 days

• Hospital Readmission Rate

  Up to 30 days

• Treatment Failure Rate at Day 7

  7 days

• Time to Resolution of Respiratory Symptoms

  Up to 30 days

Study Arms (2)

Intervention Group (Doxycycline)

EXPERIMENTAL

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: Doxycycline

Control Group (Azithromycin)

ACTIVE COMPARATOR

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).

Drug: Azithromycin

Interventions

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.

Intervention Group (Doxycycline)

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.

Control Group (Azithromycin)

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Young June Choe: lead
• Korea Society of Pediatric Infectious Diseases: collaborator
• Korea National Institute of Health: collaborator
• Korea Disease Control and Prevention Agency: collaborator
• DT&CRO: collaborator

Study Sites (14)

Department of Pediatrics, Pusan National University School of Medicine, Pusan National University Children's Hospital, Yangsan, Republic of Korea

Busan, South Korea

Location

Department of Pediatrics, Gyeongsang National University College of Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea

Changwon, South Korea

Location

Department of Pediatrics, Chosun University College of Medicine, Chosun University Hospital, Gwangju, Republic of Korea

Gwangju, South Korea

Location

Department of Pediatrics, Jeju National University School of Medicine, Jeju National University Hospital, Jeju, Republic of Korea

Jeju City, South Korea

Location

Department of Pediatrics, CHA University School of Medicine, CHA Bundang Medical Center, Seongnam, Republic of Korea

Seongnam, South Korea

Location

Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea

Seongnam, South Korea

Location

Department of Pediatrics, College of Medicine, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea

Seoul, South Korea

Location

Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea

Seoul, South Korea

Location

Department of Pediatrics, Eulji University School of Medicine, Eulji University Hospital, Seoul, Republic of Korea

Seoul, South Korea

Location

Department of Pediatrics, Korea University College of Medicine, Korea University Anam Hospital, Seoul, Republic of Korea

Seoul, South Korea

Location

Department of Pediatrics, Korea University College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea

Seoul, South Korea

Location

Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea

Seoul, South Korea

Location

Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea

Seoul, South Korea

Location

Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea

Seoul, South Korea

Location

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• 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. doi: 10.1086/508667. Epub 2006 Oct 2.

  PMID: 17029130 RESULT

• Cummings MM. Copyright and reproduction. Bull Med Libr Assoc. 1973 Jul;61(3):344-5. No abstract available.

  PMID: 4725345 RESULT

• 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 RESULT

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• Han S, Luo Y, Liu B, Guo T, Qin D, Luo F. Dietary flavonoids prevent diabetes through epigenetic regulation: advance and challenge. Crit Rev Food Sci Nutr. 2023 Nov;63(33):11925-11941. doi: 10.1080/10408398.2022.2097637. Epub 2022 Jul 11.

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• Morozumi M, Hasegawa K, Kobayashi R, Inoue N, Iwata S, Kuroki H, Kawamura N, Nakayama E, Tajima T, Shimizu K, Ubukata K. Emergence of macrolide-resistant Mycoplasma pneumoniae with a 23S rRNA gene mutation. Antimicrob Agents Chemother. 2005 Jun;49(6):2302-6. doi: 10.1128/AAC.49.6.2302-2306.2005.

  PMID: 15917525 RESULT

• Tolbert K, Stubbs E. Rational use of gastroprotectants in cats: An evidence-based approach. J Feline Med Surg. 2024 Aug;26(8):1098612X241274235. doi: 10.1177/1098612X241274235.

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• MacGowan AP, Noel AR, Tomaselli S, Bowker KE. Pharmacodynamics of ceftaroline against Staphylococcus aureus studied in an in vitro pharmacokinetic model of infection. Antimicrob Agents Chemother. 2013 Jun;57(6):2451-6. doi: 10.1128/AAC.01386-12. Epub 2013 Mar 4.

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• Roddy SP, Darling RC 3rd, Chang BB, Kreienberg PB, Paty PS, Lloyd WE, Shah DM. Brachial artery reconstruction for occlusive disease: a 12-year experience. J Vasc Surg. 2001 Apr;33(4):802-5. doi: 10.1067/mva.2001.112705.

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MeSH Terms

Conditions

Pneumonia, Mycoplasma

Interventions

Doxycycline; Azithromycin

Condition Hierarchy (Ancestors)

Mycoplasma Infections; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Central Study Contacts

Young June Choe, MD

CONTACT

+82-10-5943-0133; choey@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KR (14)