NCT03530319

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

3.1 years

First QC Date

April 29, 2018

Last Update Submit

July 27, 2021

Conditions

Pneumonia, Mycoplasma

Keywords

Mycoplasma pneumoniaeMacrolide-resistanceChildren

Outcome Measures

Primary Outcomes (1)

  • Defervescence

    The timing (days) when fever subsides after treatment

    Up to 10 days

Secondary Outcomes (1)

  • Hospital stay

    Up to 2 weeks

Study Arms (2)

Azithromycin

ACTIVE COMPARATOR

Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.

Drug: Azithromycin

Doxycycline

EXPERIMENTAL

Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.

Drug: Doxycycline

Interventions

DoxycyclineDRUG

Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.

Doxycycline
AzithromycinDRUG

Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.

Azithromycin

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pneumonia, Mycoplasma

Interventions

DoxycyclineAzithromycin

Condition Hierarchy (Ancestors)

Mycoplasma InfectionsMycoplasmatales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumonia, BacterialPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsErythromycinMacrolidesPolyketidesLactones

Central Study Contacts

Chun-Yi Lu, MD, PhD

CONTACT

886-2-23123456cylu@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2018

First Posted

May 21, 2018

Study Start

November 10, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)