Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
208 participants
INTERVENTIONAL
2026-03-01
2029-02-28
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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).
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. Consistent with the intention-to-treat principle, these cases will be classified as treatment failures for the primary efficacy analysis.
Interventions
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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.
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. Consistent with the intention-to-treat principle, these cases will be classified as treatment failures for the primary efficacy analysis.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
17 Years
ALL
No
Sponsors
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Korea Society of Pediatric Infectious Diseases
UNKNOWN
Korea National Institute of Health
UNKNOWN
Korea Disease Control and Prevention Agency
UNKNOWN
DT&CRO
UNKNOWN
Young June Choe
OTHER
Responsible Party
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Young June Choe
Professor
Locations
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Department of Pediatrics, Pusan National University School of Medicine, Pusan National University Children's Hospital, Yangsan, Republic of Korea
Busan, , South Korea
Department of Pediatrics, Gyeongsang National University College of Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea
Changwon, , South Korea
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
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
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
Countries
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Central Contacts
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Facility Contacts
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Kyo Jin Jo, MD
Role: primary
Kyung-Ran Kim, MD
Role: primary
Gahee Kim, MD
Role: primary
Jae Hong Choi, MD
Role: primary
Taek Jin Lee, MD
Role: primary
Hyunju Lee, MD
Role: primary
Ui Yoon Choi, MD
Role: primary
Hyun Mi Kang, MD
Role: primary
Byung Wook Eun, MD
Role: primary
Youn Young Choi, MD
Role: primary
Yoon Sun Yoon, MD
Role: primary
Ki Wook Yun, MD
Role: primary
Bin Ahn, MD
Role: primary
Doo Ri Kim, MD
Role: primary
References
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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.
Cummings MM. Copyright and reproduction. Bull Med Libr Assoc. 1973 Jul;61(3):344-5. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KNIH
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DOMINO
Identifier Type: -
Identifier Source: org_study_id