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Treatment of Macrolide-resistant Mycoplasma Pneumoniae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03530319
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : June 18, 2020
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.

Condition or disease Intervention/treatment Phase
Pneumonia, Mycoplasma Drug: Doxycycline Drug: Azithromycin Not Applicable

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. Genotyping based on multiple-locus variable-number tandem-repeat and resistance analysis (MLVA) will be used to study the classification and possibly the evolution of M. pneumoniae strains. 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. On the other hand, the investigators are going to update the macrolide-resistant rates in Taiwan and analyze M. pneumoniae strains in Taiwan by MLVA. By using this rapid and highly discriminatory tool, the investigators could provide more reliable information about the relationship between resistance strains

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Studies on Macrolide-resistant Mycoplasma Pneumoniae in Taiwan- A Randomized Control Trial and MLVA Analysis
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: Azithromycin
Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.
Drug: Azithromycin
Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.

Experimental: Doxycycline
Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.
Drug: Doxycycline
Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.

Primary Outcome Measures :
  1. Defervescence [ Time Frame: Up to 10 days ]
    The timing (days) when fever subsides after treatment

Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: Up to 2 weeks ]
    The length of hospitalization

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 1-18 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:

  • Patients who have already taken macrolides, tetracyclines, or fluoroquinolones.
  • Patient's with congenital or acquired immunodeficiency.
  • Severe patients who needs ICU care.
  • Patients or their guardians who are not willing to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03530319

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Contact: Chun-Yi Lu, MD, PhD 886-2-23123456 ext 71550

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chun-Yi Lu, MD, PhD    886-2-23123456 ext 71550   
Sponsors and Collaborators
National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT03530319    
Other Study ID Numbers: 201712140MIND
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Mycoplasma pneumoniae
Additional relevant MeSH terms:
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Mycoplasma Infections
Pneumonia, Mycoplasma
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pleural Diseases
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents