Pneumonia, MycoplasmaNCT03530319
Treatment of Macrolide-resistant Mycoplasma Pneumoniae
A study testing Doxycycline and Azithromycin in people with Pneumonia, Mycoplasma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pneumonia, Mycoplasma
- What is being tested?
- Doxycycline and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chun-Yi Lu, MD, PhD, 886-2-23123456 ext. 71550, cylu@ntu.edu.tw
About this study
Official title: Studies on Macrolide-resistant Mycoplasma Pneumoniae in Taiwan- A Randomized Control Trial and MLVA Analysis
A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.
Read the 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
- Conditions
- Pneumonia, Mycoplasma
- Being tested
- Doxycycline, Azithromycin
- Keywords
- Mycoplasma pneumoniae, Macrolide-resistance, Children
- Medical subject headings
- Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.
AzithromycinDrug
Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Active comparator | Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days. Receives: Drug: Azithromycin |
| Doxycycline | Experimental | Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days. Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defervescence
The timing (days) when fever subsides after treatment
Measured: Up to 10 days
Secondary outcomes (1)
Hospital stay
The length of hospitalization
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start10 Nov 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, MycoplasmaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530319
- Sponsor's protocol ID
- 201712140MIND
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on Macrolide-resistant Mycoplasma Pneumoniae in Taiwan- A Randomized Control Trial and MLVA Analysis
- ClinicalTrials.gov ID
- NCT03530319
- Acronym / sponsor ID
- 201712140MIND
- Conditions
- Pneumonia, Mycoplasma
- Keywords
- Mycoplasma pneumoniae, Macrolide-resistance, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Active comparator | Drug: AzithromycinAzithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days. |
| Doxycycline | Experimental | Drug: DoxycyclineDoxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineOral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days. | Drug | Doxycycline |
| AzithromycinAzithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days. | Drug | Azithromycin |
Primary outcome
Defervescence
Time frame: Up to 10 days
The timing (days) when fever subsides after treatment
1 secondary outcome
Hospital stay
Time frame: Up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline and Azithromycin in people with Pneumonia, Mycoplasma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yi Lu, MD, PhD (886-2-23123456 ext. 71550, cylu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defervescence (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.