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| ID | Type | Description | Link |
|---|---|---|---|
| KNIH | Other Grant/Funding Number | National Institute of Health, Korea Disease Control and Prevention Agency |
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| Name | Class |
|---|---|
| Korea Society of Pediatric Infectious Diseases | UNKNOWN |
| National Institute of Health, Korea | OTHER_GOV |
| Korea Disease Control and Prevention Agency | UNKNOWN |
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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:
Researchers will compare doxycycline to azithromycin to see if doxycycline works better to treat this type of pneumonia.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization Rate | Percentage of participants requiring hospitalization due to the progression of pneumonia or complications. | Up to 30 days |
| Length of Hospital Stay | The duration of hospitalization from admission to discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young June Choe, MD | Contact | +82-10-5943-0133 | choey@korea.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Pusan National University School of Medicine, Pusan National University Children's Hospital, Yangsan, Republic of Korea | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17029130 | Result | 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. | |
| 4725345 |
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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.
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| DT&CRO |
| UNKNOWN |
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|
| 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. |
|
| Up to 30 days |
| Hospital Readmission Rate | Percentage of participants readmitted to the hospital after initial discharge due to worsening of pneumonia. | Up to 30 days |
| 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. | 7 days |
| 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 | Up to 30 days |
| Time to Radiological Resolution of Infiltrates | Time to resolution of pulmonary infiltrates as confirmed by chest radiography follow-up. | Up to 30 days |
| Incidence of Tooth Discoloration in Children Under 8 Years | Assessment of visible tooth discoloration evaluated by visual inspection. | Day 28 |
| Department of Pediatrics, Gyeongsang National University College of Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea | Changwon | South Korea |
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| Department of Pediatrics, Chosun University College of Medicine, Chosun University Hospital, Gwangju, Republic of Korea | Gwangju | South Korea |
|
| Department of Pediatrics, Jeju National University School of Medicine, Jeju National University Hospital, Jeju, Republic of Korea | Jeju City | South Korea |
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| Department of Pediatrics, CHA University School of Medicine, CHA Bundang Medical Center, Seongnam, Republic of Korea | Seongnam | South Korea |
|
| Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea | Seongnam | South Korea |
|
| Department of Pediatrics, College of Medicine, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea | Seoul | South Korea |
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| Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea | Seoul | South Korea |
|
| Department of Pediatrics, Eulji University School of Medicine, Eulji University Hospital, Seoul, Republic of Korea | Seoul | South Korea |
|
| Department of Pediatrics, Korea University College of Medicine, Korea University Anam Hospital, Seoul, Republic of Korea | Seoul | South Korea |
|
| Department of Pediatrics, Korea University College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea | Seoul | South Korea |
|
| Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea | Seoul | South Korea |
|
| Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea | Seoul | South Korea |
|
| Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea | Seoul | South Korea |
|
| Result |
| Cummings MM. Copyright and reproduction. Bull Med Libr Assoc. 1973 Jul;61(3):344-5. No abstract available. |
| 22805273 | 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. |
| 39145892 | 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. |
| 38505587 | Result | 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. |
| 24277028 | Result | 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. |
| 25572886 | Result | 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. |
| 35687640 | Result | 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. |
| 35816298 | Result | 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. |
| 15917525 | Result | 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. |
| 39105658 | 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. |
| 23459495 | Result | 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. |
| 11296335 | Result | 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. |
| 42191206 | Derived | 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. |
| ID | Term |
|---|---|
| D011019 | Pneumonia, Mycoplasma |
| ID | Term |
|---|---|
| D009175 | Mycoplasma Infections |
| D009180 | Mycoplasmatales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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