Treatment and Vaccine Development of Mycoplasma Pneumoniae

• ClinicalTrials.gov Identifier: NCT03911440
• Recruitment Status: Recruiting
• First Posted: April 11, 2019
• Last Update Posted: April 11, 2019
• Sponsor: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

Tracking Information

• First Submitted Date: April 9, 2019
• First Posted Date: April 11, 2019
• Last Update Posted Date: April 11, 2019
• Actual Study Start Date: November 10, 2018
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2019)

Defervescence [ Time Frame: Up to 10 days ]

The timing (days) when fever subsides after treatment

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 9, 2019)

Hospital stay [ Time Frame: Up to 2 weeks ]

The length of hospitalization

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment and Vaccine Development of Mycoplasma Pneumoniae
• Official Title: Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development
• Brief Summary: A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.
• Detailed Description: Mycoplasma pneumoniae accounts for 10-30% of community-acquired pneumonia (CAP) in children. Proportionally, M. pneumoniae has become the most important pathogen for childhood pneumonia after the widespread use of Streptococcus pneumoniae vaccines. M. pneumoniae is routinely treated with antibiotics, and the macrolides antibiotics are the drug of choice for M. pneumonia infection. However, macrolide-resistance rates have increased to 20 and 100% in Asia. In previous studies, the most common mutation point, A2063G, was detected from 23% of local strains in Taiwan. The evolution and spreading of Mycoplasma in Taiwan and different countries are unknown. While the macrolide-resistance is increasing, the optimal therapy remains unclear. Both tetracyclines and fluoroquinolones showed promises in treating macrolide-resistant M. pneumoniae in adults. However, their use in children is not recommended due to safety concerns. Recently, evidence are accumulating that doxycycline, unlike other tetracyclines, does not cause staining of teeth. In the current study, the investigators are going to carry out a randomized control trial to compare the efficacy and safety of doxycycline against macrolide-resistant M. pneumoniae.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Atypical Pneumonia

Intervention

• Drug: Doxycycline
  Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.
• Drug: Azithromycin
  Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.

Study Arms

• Active Comparator: Azithromycin
  Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.
  Intervention: Drug: Azithromycin
• Experimental: Doxycycline
  Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.
  Intervention: Drug: Doxycycline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 9, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Children aged 0-18 years, admitted due to lower respiratory tract infections. Mycoplamsa pneumonia is diagnosed.
• The diagnosis is made within 72 hours after fever onset.
• The patient and his/her guardians are willing to participate the study and able to follow the instruction.

Exclusion Criteria:

• None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Li-Min Huang, MD, PhD; 886-2-23123456 ext 71525; lmhuang@ntu.edu.tw

• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT03911440
• Other Study ID Numbers: 201712045MINA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: National Taiwan University Hospital
• Study Sponsor: National Taiwan University Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: National Taiwan University Hospital
• Verification Date: April 2019