Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:29 AM
Study NCT ID:
NCT07306234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxycycline vs. Macrolide for MRMP (DOMINO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011019', 'term': 'Pneumonia, Mycoplasma'}], 'ancestors': [{'id': 'D009175', 'term': 'Mycoplasma Infections'}, {'id': 'D009180', 'term': 'Mycoplasmatales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-24', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Defervescence rate', 'timeFrame': '72 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization Rate', 'timeFrame': 'Up to 30 days', 'description': 'Percentage of participants requiring hospitalization due to the progression of pneumonia or complications.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Up to 30 days', 'description': 'The duration of hospitalization from admission to discharge.'}, {'measure': 'Hospital Readmission Rate', 'timeFrame': 'Up to 30 days', 'description': 'Percentage of participants readmitted to the hospital after initial discharge due to worsening of pneumonia.'}, {'measure': 'Treatment Failure Rate at Day 7', 'timeFrame': '7 days', 'description': '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.'}, {'measure': 'Time to Resolution of Respiratory Symptoms', 'timeFrame': 'Up to 30 days', 'description': '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'}, {'measure': 'Time to Radiological Resolution of Infiltrates', 'timeFrame': 'Up to 30 days', 'description': 'Time to resolution of pulmonary infiltrates as confirmed by chest radiography follow-up.'}, {'measure': 'Incidence of Tooth Discoloration in Children Under 8 Years', 'timeFrame': 'Day 28', 'description': 'Assessment of visible tooth discoloration evaluated by visual inspection.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mycoplasma pneumoniae', 'Macrolide resistance', 'Children'], 'conditions': ['Mycoplasma Pneumoniae', 'Mycoplasma Pneumoniae Pneumonia']}, 'referencesModule': {'references': [{'pmid': '17029130', 'type': 'RESULT', 'citation': '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': '4725345', 'type': 'RESULT', 'citation': 'Cummings MM. Copyright and reproduction. Bull Med Libr Assoc. 1973 Jul;61(3):344-5. No abstract available.'}, {'pmid': '22805273', 'type': 'RESULT', 'citation': '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': '39145892', 'type': 'RESULT', 'citation': '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': '38505587', 'type': 'RESULT', 'citation': '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': '24277028', 'type': 'RESULT', 'citation': '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': '25572886', 'type': 'RESULT', 'citation': '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': '35687640', 'type': 'RESULT', 'citation': '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': '35816298', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '15917525', 'type': 'RESULT', 'citation': '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': '39105658', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23459495', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '11296335', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Does doxycycline stop fevers faster than azithromycin?\n* Is doxycycline safe for children, specifically regarding tooth color changes?\n\nResearchers will compare doxycycline to azithromycin to see if doxycycline works better to treat this type of pneumonia.\n\nParticipants will:\n\n* Take either doxycycline or azithromycin by mouth for 7 to 14 days.\n* Check their body temperature to see when their fever goes away.\n* Visit the hospital to check for any medical problems.\n* Have their teeth checked for color changes 28 days after starting the medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 3 to 17 years at the time of enrollment.\n* Diagnosis: Clinically diagnosed CAP characterized by respiratory symptoms (e.g., fever, cough, auscultatory findings) and chest X-ray confirming pulmonary infiltrates.\n* 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).\n* Resistance: Suspected macrolide-resistant M. pneumoniae (MRMP) infection (e.g., during a reported local epidemic of MRMP).\n* Timing: Ability to register and initiate the study drug within 72 hours of symptom onset.\n\nExclusion Criteria:\n\n* Prior use of tetracyclines, macrolides, or quinolones for the current illness.\n* Complicated pneumonia (e.g., necrosis, empyema, lung abscess) or severe pneumonia requiring immediate intensive care or exhibiting hypoxia (SpO₂ \\<90%).\n* Hypersensitivity or contraindications to macrolides or tetracyclines.\n* Severe immunocompromised state or severe underlying lung disease.\n* Severe hepatic impairment (AST/ALT \\>3x upper limits) or severe renal impairment.'}, 'identificationModule': {'nctId': 'NCT07306234', 'acronym': 'DOMINO', 'briefTitle': 'Doxycycline vs. Macrolide for MRMP (DOMINO)', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Efficacy and Safety of Doxycycline Versus Macrolides for Mycoplasma Pneumoniae Infection in Children (DOMINO): A Protocol for a Multicenter, Randomized, Open-Label, Superiority Trial', 'orgStudyIdInfo': {'id': 'DOMINO'}, 'secondaryIdInfos': [{'id': 'KNIH', 'type': 'OTHER_GRANT', 'domain': 'National Institute of Health, Korea Disease Control and Prevention Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (Doxycycline)', 'description': '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.', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (Azithromycin)', 'description': '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).', 'interventionNames': ['Drug: Azithromycin']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Intervention Group (Doxycycline)']}, {'name': 'Azithromycin', 'type': 'DRUG', 'description': '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).\n\nRescue 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.', 'armGroupLabels': ['Control Group (Azithromycin)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'contacts': [{'name': 'Kyo Jin Jo, MD', 'role': 'CONTACT', 'email': 'godjkj@nate.com', 'phone': '+82-10-5943-0133'}], 'facility': "Department of Pediatrics, Pusan National University School of Medicine, Pusan National University Children's Hospital, Yangsan, Republic of Korea", 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Changwon', 'country': 'South Korea', 'contacts': [{'name': 'Kyung-Ran Kim, MD', 'role': 'CONTACT', 'email': 'kkran82@gmail.com', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Gyeongsang National University College of Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Gwangju', 'country': 'South Korea', 'contacts': [{'name': 'Gahee Kim, MD', 'role': 'CONTACT', 'email': 'pauelf01@gmail.com', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Chosun University College of Medicine, Chosun University Hospital, Gwangju, Republic of Korea', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Jeju City', 'country': 'South Korea', 'contacts': [{'name': 'Jae Hong Choi, MD', 'role': 'CONTACT', 'email': 'pedidongs@gmail.com', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Jeju National University School of Medicine, Jeju National University Hospital, Jeju, Republic of Korea', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}, {'city': 'Seongnam', 'country': 'South Korea', 'contacts': [{'name': 'Taek Jin Lee, MD', 'role': 'CONTACT', 'email': 'bjloveu@daum.net', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, CHA University School of Medicine, CHA Bundang Medical Center, Seongnam, Republic of Korea', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seongnam', 'country': 'South Korea', 'contacts': [{'name': 'Hyunju Lee, MD', 'role': 'CONTACT', 'email': 'hyunjulee@snu.ac.kr', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Ui Yoon Choi, MD', 'role': 'CONTACT', 'email': 'uiyoon@catholic.ac.kr', 'phone': '+82-10-5943-0133'}], 'facility': "Department of Pediatrics, College of Medicine, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Mi Kang, MD', 'role': 'CONTACT', 'email': 'pedhmk@catholic.ac.kr', 'phone': '+82-10-5943-0133'}], 'facility': "Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Byung Wook Eun, MD', 'role': 'CONTACT', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Eulji University School of Medicine, Eulji University Hospital, Seoul, Republic of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Youn Young Choi, MD', 'role': 'CONTACT', 'email': 'cyypedr@korea.ac.kr', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Korea University College of Medicine, Korea University Anam Hospital, Seoul, Republic of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Yoon Sun Yoon, MD', 'role': 'CONTACT', 'email': 'yhappy815@gmail.com', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Korea University College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Ki Wook Yun, MD', 'role': 'CONTACT', 'email': 'pedwilly@snu.ac.kr', 'phone': '+82-10-5943-0133'}], 'facility': "Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Bin Ahn, MD', 'role': 'CONTACT', 'email': 'ahnnybinny@gmail.com', 'phone': '+82-10-5943-0133'}], 'facility': "Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Doo Ri Kim, MD', 'role': 'CONTACT', 'email': 'doori756.kim@samsung.com', 'phone': '+82-10-5943-0133'}], 'facility': 'Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Young June Choe, MD', 'role': 'CONTACT', 'email': 'choey@korea.ac.kr', 'phone': '+82-10-5943-0133'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': '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.\n\nSupporting 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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Young June Choe', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Society of Pediatric Infectious Diseases', 'class': 'UNKNOWN'}, {'name': 'Korea National Institute of Health', 'class': 'UNKNOWN'}, {'name': 'Korea Disease Control and Prevention Agency', 'class': 'UNKNOWN'}, {'name': 'DT&CRO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young June Choe', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}