Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza PatientsNCT04315194
Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients
An observational study of Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients
- What is being tested?
- clarithromycin-naproxen-oseltamivir
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Dec 2017to 29 Dec 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
Study population: The study was conducted at Mackay Children's Hospital, Taiwan, between December 2017 and December 2019.
Who may be able to join
- age 1 year to 18 years; body temperature higher than 38 °C; presence of one of the following symptoms-cough, sputum production, sore throat, rhinorrhoea, myalgia, headache, or fatigue presenting within 72 hours from symptom onset; laboratory-confirmed influenza infection (including rapid test or PCR-confirmed influenza A or B); and clinical requirement for hospitalisation. Antiviral treatment was initiated within 48 hours after admission.
Who cannot join
- a history of allergy or contraindication to the study medications; the administration of medications with macrolides (ex: azithromycin, erythromycin), naproxen or neuraminidase inhibitor use within 72 hours; current use of any antibiotic; and the presence of an immunocompromised state due to steroid use, human immunodeficiency virus infection, chronic kidney disease, renal failure, chemotherapy or radiotherapy in half year, or innate immunodeficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients
Read the detailed description
This study aimed to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients. This prospective, single-blinded study included patients hospitalised for influenza infection aged 1 year to 18 years, at MacKay Children's Hospital, Taiwan, between December 2017 and December 2019. The primary outcomes were respiratory symptom severity and the signs that presented within hospitalisation. The durations of fever and hospital stay were also documented. The secondary outcome measures were serial changes in the virus titres, as detected by real-time polymerase chain reaction. Totally 54 patients were enrolled (28 in the control group and 26 in the combination group). There were no differences in the patients' baseline characteristics between the groups. The time to defervescence was significantly shorter in the combination group than the oseltamivir group (13.2 hours vs 32.1 hours, p=0.002). The decrease in the virus titre was more pronounced from days 1 to 3 (log Δ13) in the combination group than the oseltamivir group.(log Δ13: 39% vs 19%, p=0.001). In paediatric settings, combination therapy may be used selectively among patients with a history of febrile convulsion or families anxious about the discomforts associated with the fever itself.
- Being tested
- clarithromycin-naproxen-oseltamivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin-naproxen-oseltamivirDrug
to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients.
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin-naproxen-oseltamivir | Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients Receives: Drug: clarithromycin-naproxen-oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of symptoms and signs
severity of symptoms and signs presenting on the first, third, and fifth days of admission, including cough, sputum, rhinorrhoea, sore throat, chills, wheezing/stridor, headache, dizziness, shortness of breath, chest pain, vomiting, diarrhoea, muscle pain, and abdominal pain. The duration of fever and length of hospital stay after treatment were also documented.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start18 Dec 2017
- Primary completion29 Dec 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Wei Lee, Dr., Principal investigator, Mackay Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315194
- Sponsor's protocol ID
- MackayMH
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data used to support the findings of this study have not been made available due to legal restrictions imposed by the government of Taiwan in relation to the "Personal Information Protection Act", personal data cannot be made publicly available. However, the investigators could provide disconnected data as follows: https://drive.google.com/open?id=1zcCZKNBO7kfJFt8AcuZd1Yi2PniAAlwe
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients
- ClinicalTrials.gov ID
- NCT04315194
- Acronym / sponsor ID
- MackayMH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 19 Mar 2020 (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.
Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients
Detailed description
This study aimed to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients. This prospective, single-blinded study included patients hospitalised for influenza infection aged 1 year to 18 years, at MacKay Children's Hospital, Taiwan, between December 2017 and December 2019. The primary outcomes were respiratory symptom severity and the signs that presented within hospitalisation. The durations of fever and hospital stay were also documented. The secondary outcome measures were serial changes in the virus titres, as detected by real-time polymerase chain reaction. Totally 54 patients were enrolled (28 in the control group and 26 in the combination group). There were no differences in the patients' baseline characteristics between the groups. The time to defervescence was significantly shorter in the combination group than the oseltamivir group (13.2 hours vs 32.1 hours, p=0.002). The decrease in the virus titre was more pronounced from days 1 to 3 (log Δ13) in the combination group than the oseltamivir group.(log Δ13: 39% vs 19%, p=0.001). In paediatric settings, combination therapy may be used selectively among patients with a history of febrile convulsion or families anxious about the discomforts associated with the fever itself.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clarithromycin-naproxen-oseltamivir | – | Drug: clarithromycin-naproxen-oseltamivirEfficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study was conducted at Mackay Children's Hospital, Taiwan, between December 2017 and December 2019.
Key inclusion criteria (1 listed)
- age 1 year to 18 years; body temperature higher than 38 °C; presence of one of the following symptoms-cough, sputum production, sore throat, rhinorrhoea, myalgia, headache, or fatigue presenting within 72 hours from symptom onset; laboratory-confirmed influenza infection (including rapid test or PCR-confirmed influenza A or B); and clinical requirement for hospitalisation. Antiviral treatment was initiated within 48 hours after admission.
Key exclusion criteria (1 listed)
- a history of allergy or contraindication to the study medications; the administration of medications with macrolides (ex: azithromycin, erythromycin), naproxen or neuraminidase inhibitor use within 72 hours; current use of any antibiotic; and the presence of an immunocompromised state due to steroid use, human immunodeficiency virus infection, chronic kidney disease, renal failure, chemotherapy or radiotherapy in half year, or innate immunodeficiency.
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 |
|---|---|---|
| clarithromycin-naproxen-oseltamivirto compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients. | Drug | clarithromycin-naproxen-oseltamivir |
Primary outcome
severity of symptoms and signs
Time frame: 1 month
severity of symptoms and signs presenting on the first, third, and fifth days of admission, including cough, sputum, rhinorrhoea, sore throat, chills, wheezing/stridor, headache, dizziness, shortness of breath, chest pain, vomiting, diarrhoea, muscle pain, and abdominal pain. The duration of fever and length of hospital stay after treatment were also documented.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: Undecided. The data used to support the findings of this study have not been made available due to legal restrictions imposed by the government of Taiwan in relation to the "Personal Information Protection Act", personal data cannot be made publicly available. However, the investigators could provide disconnected data as follows: https://drive.google.com/open?id=1zcCZKNBO7kfJFt8AcuZd1Yi2PniAAlwe
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.
Chien-Wei Lee, Dr. principal investigator
Mackay Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients, run by Mackay Memorial 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of symptoms and signs (time frame: 1 month). 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 19 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.