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Mycoplasma PneumoniaePhase 4DOMINONCT07306234

Doxycycline vs. Macrolide for MRMP (DOMINO)

A Phase 4 study testing Doxycycline and Azithromycin in people with Mycoplasma Pneumoniae and Mycoplasma Pneumoniae Pneumonia, run by Young June Choe at 14 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 3 to 17 years
What is being tested?
Doxycycline and Azithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
14 sitesSouth Korea
Study dates
1 Mar 2026to 28 Feb 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Young June Choe, MD contact

+82-10-5943-0133

choey@korea.ac.kr

14 sites in 1 country

South Korea14 sites
  • Department of Pediatrics, Pusan National University School of Medicine, Pusan National University Children's Hospital, Yangsan, Republic of Korea

    Busan

    Kyo Jin Jo, MD, +82-10-5943-0133, godjkj@nate.com

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

    Changwon

    Kyung-Ran Kim, MD, +82-10-5943-0133, kkran82@gmail.com

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

    Gwangju

    Gahee Kim, MD, +82-10-5943-0133, pauelf01@gmail.com

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

    Jeju City

    Jae Hong Choi, MD, +82-10-5943-0133, pedidongs@gmail.com

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

    Seongnam

    Taek Jin Lee, MD, +82-10-5943-0133, bjloveu@daum.net

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

    Seongnam

    Hyunju Lee, MD, +82-10-5943-0133, hyunjulee@snu.ac.kr

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

    Seoul

    Ui Yoon Choi, MD, +82-10-5943-0133, uiyoon@catholic.ac.kr

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

    Seoul

    Hyun Mi Kang, MD, +82-10-5943-0133, pedhmk@catholic.ac.kr

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

    Seoul

    Byung Wook Eun, MD, +82-10-5943-0133

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

    Seoul

    Youn Young Choi, MD, +82-10-5943-0133, cyypedr@korea.ac.kr

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

    Seoul

    Yoon Sun Yoon, MD, +82-10-5943-0133, yhappy815@gmail.com

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

    Seoul

    Ki Wook Yun, MD, +82-10-5943-0133, pedwilly@snu.ac.kr

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

    Seoul

    Bin Ahn, MD, +82-10-5943-0133, ahnnybinny@gmail.com

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

    Seoul

    Doo Ri Kim, MD, +82-10-5943-0133, doori756.kim@samsung.com

Other trials in South Korea

About this study

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

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?
Read more

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.
Being tested
Doxycycline, Azithromycin
Keywords
Mycoplasma pneumoniae, Macrolide resistance, Children
Medical subject headings
Pneumonia, Mycoplasma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxycyclineDrug

    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.

  • AzithromycinDrug

    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.

Study groups in NCT07306234
Study groupRoleWhat they receive
Intervention Group (Doxycycline)ExperimentalParticipants 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.
Receives: Drug: Doxycycline
Control Group (Azithromycin)Active comparatorParticipants 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).
Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 72 hours

Secondary outcomes (7)
  1. Hospitalization Rate

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

    Measured: Up to 30 days

  2. Length of Hospital Stay

    The duration of hospitalization from admission to discharge.

    Measured: Up to 30 days

  3. Hospital Readmission Rate

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

    Measured: 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.

    Measured: 7 days

  5. Time to Resolution of Respiratory Symptoms

    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

    Measured: Up to 30 days

  6. Time to Radiological Resolution of Infiltrates

    Time to resolution of pulmonary infiltrates as confirmed by chest radiography follow-up.

    Measured: Up to 30 days

  7. Incidence of Tooth Discoloration in Children Under 8 Years

    Assessment of visible tooth discoloration evaluated by visual inspection.

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07306234
Sponsor's protocol ID
DOMINO
Other IDs
KNIH
Acronym
DOMINO
Status last verified
Dec 2025
First submitted
22 Dec 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in the publication will be made available to researchers who provide a methodologically sound proposal. This includes text, tables, figures, and appendices. IPD will be available beginning 6 months and ending 36 months following article publication. Supporting Information: The study protocol, statistical analysis plan (SAP), and informed consent form will also be shared. Access Criteria: Proposals should be directed to the Principal Investigator at \[Insert Official Email Address\]. To gain access, data requestors will need to sign a data access agreement.

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

    PubMed 17029130
  • Cummings MM. Copyright and reproduction. Bull Med Libr Assoc. 1973 Jul;61(3):344-5. No abstract available.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35687640
  • 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.

    PubMed 35816298
  • 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.

    PubMed 15917525
  • 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.

    PubMed 39105658
  • 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.

    PubMed 23459495
  • 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.

    PubMed 11296335
  • Choi YY, Kang C, Choe YJ, Yoo Y, Shin A, Kim DR, Ahn B, Eun BW, Kim G, Kang HM, Kim YJ, Cho YK, Lee H, Kim YK, Choi JH, Yun KW, Jo KJ, Kim KR, Lee TJ, Choi UY, Yoon YS, Kim J, Kang MS, Park SK, Yang WM, Lee S. Efficacy and safety of Doxycycline versus Macrolides for Mycoplasma pneumoniae INfectiOn in Children (DOMINO): a protocol for a multicentre, randomised, open-label, superiority trial. BMJ Open. 2026 May 26;16(5):e117862. doi: 10.1136/bmjopen-2026-117862.

    PubMed 42191206

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Doxycycline and Azithromycin in people with Mycoplasma Pneumoniae and Mycoplasma Pneumoniae Pneumonia, run by Young June Choe at 14 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Young June Choe, MD (+82-10-5943-0133, choey@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Defervescence rate (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07306234, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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