Respiratory Syncytial VirusPhase 2NCT02707523
Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
A Phase 2 study testing Azithromycin 10 mg and Azithromycin 20mg in people with Respiratory Syncytial Virus, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- Azithromycin 10 mg and Azithromycin 20mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 20 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to the PICU with RSV infection
- Need for positive pressure ventilation (invasive and non-invasive)
- Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit
Who cannot join
- Azithromycin use within 7 days of PICU admission
- Contraindication to azithromycin use including:
- Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450 ms
- Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)
- Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug
- Cardiac arrhythmia
Show all 9Show fewer
- History of pyloric stenosis
- Immunocompromised children (any cause)
- Current use of any medication known to cause QT prolongation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Pilot Clinical Trial of Azithromycin Treatment In RSV-induced Respiratory Failure In Children
This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).
Read the detailed description
Eligible participants include all children admitted to the PICU at Children's of Alabama with a diagnosis of RSV infection and requiring positive pressure ventilation, invasive or noninvasive, including bilevel positive airway pressure (BiPAP) or high flow nasal cannula (HFNC) oxygen (ie, >1 L/kg/min of flow, with 5 L/min flow for children weighing <5 kg). During hospitalization, all patients will be treated according to the American Academy of Pediatrics guidelines for the management of bronchiolitis, primarily supportive care. Participants will then be randomized according to a permuted-block design to receive either placebo (saline) or AZM (Fresenius Kabi) at 10mg/kg/d (ie, standard dose) or 20mg/kg/d (ie, high dose) intravenously every 24 hours for 3 days. All biologic samples collected will be analyzed in the PI's lab at the University of Alabama at Birmingham. Drug pharmacokinetics will be performed at the Pharmaceutical Sciences Research Institute of Samford University, Birmingham, AL.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- Azithromycin 10 mg, Azithromycin 20mg, Placebo
- Keywords
- RSV, respiratory support, ICU, Azithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 10 mgDrug
Also called Zithromax, Z-Pak
Azithromycin 20mgDrug
Also called Zithromax, Z-Pak
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo controlled (normal saline) daily for 3 days Receives: Drug: Placebo |
| Azithromycin (10 mg/kg) | Active comparator | 10 mg/kg IV Azithromycin daily for 3 days Receives: Drug: Azithromycin 10 mg |
| Azithromycin (20 mg/kg) | Active comparator | 20 mg/kg IV Azithromycin daily for 3 days Receives: Drug: Azithromycin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
To determine the safety profile of AZM at 10 mg/kg and 20 mg/kg IV X 3 days in children with RSV-induced respiratory failure
Measured: Baseline through Day 3
Nasal Total Matrix Metalloproteinase (MMP)-9 Level
To determine the concentration of total MMP-9 levels in the nasal compartment
Measured: Day 3
Pharmacokinetic-Plasma Half Life of AZM
Measurement of AZM half life in the plasma
Measured: From baseline to 72 hours post treatment
Pharmacokinetic-Lung Half Life of AZM
Measurement of AZM half life in the lung
Measured: From baseline to 72 hours post treatment
Secondary outcomes (6)
Duration of Mechanical Ventilation in Days
Duration of mechanical ventilation in days for enrolled subjects
Measured: Pre-treatment through 2 weeks
Duration of BiPAP in Days
Duration of BiPAP in days for enrolled subjects
Measured: Pre-treatment through 2 weeks
Duration of High Flow Nasal Cannula in Days
Duration of High Flow Nasal Cannula in days for enrolled subjects
Measured: Pre-treatment through 2 weeks
Duration of Oxygenation in Days
Duration of oxygenation in days for enrolled subjects
Measured: Pre-treatment through 2 weeks
Duration of Hospitalization in Days
Duration of hospitalization in days for enrolled subjects
Measured: Pre-treatment through 2 weeks
Duration of PICU Stay in Days
Duration of PICU stay in days for enrolled subjects
Measured: Pre-treatment through 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start1 Jan 2016
- Primary completion6 Feb 2019
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Kong, University of Alabama at Birmingham
- Investigators
- Michele Kong, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707523
- Sponsor's protocol ID
- FWA00005960
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2016
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kong M, Zhang WW, Sewell K, Gorman G, Kuo HC, Aban I, Ambalavanan N, Whitley RJ. Azithromycin Treatment vs Placebo in Children With Respiratory Syncytial Virus-Induced Respiratory Failure: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e203482. doi: 10.1001/jamanetworkopen.2020.3482.
PubMed 32324238
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Clinical Trial of Azithromycin Treatment In RSV-induced Respiratory Failure In Children
- ClinicalTrials.gov ID
- NCT02707523
- Acronym / sponsor ID
- FWA00005960
- Conditions
- Respiratory Syncytial Virus
- Keywords
- RSV, respiratory support, ICU, Azithromycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).
Detailed description
Eligible participants include all children admitted to the PICU at Children's of Alabama with a diagnosis of RSV infection and requiring positive pressure ventilation, invasive or noninvasive, including bilevel positive airway pressure (BiPAP) or high flow nasal cannula (HFNC) oxygen (ie, >1 L/kg/min of flow, with 5 L/min flow for children weighing <5 kg). During hospitalization, all patients will be treated according to the American Academy of Pediatrics guidelines for the management of bronchiolitis, primarily supportive care. Participants will then be randomized according to a permuted-block design to receive either placebo (saline) or AZM (Fresenius Kabi) at 10mg/kg/d (ie, standard dose) or 20mg/kg/d (ie, high dose) intravenously every 24 hours for 3 days. All biologic samples collected will be analyzed in the PI's lab at the University of Alabama at Birmingham. Drug pharmacokinetics will be performed at the Pharmaceutical Sciences Research Institute of Samford University, Birmingham, AL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboPlacebo controlled (normal saline) daily for 3 days |
| Azithromycin (10 mg/kg) | Active comparator | Drug: Azithromycin 10 mg10 mg/kg IV Azithromycin daily for 3 days |
| Azithromycin (20 mg/kg) | Active comparator | Drug: Azithromycin 20mg20 mg/kg IV Azithromycin daily for 3 days |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Admission to the PICU with RSV infection
- Need for positive pressure ventilation (invasive and non-invasive)
- Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit
Key exclusion criteria (9 listed)
- Azithromycin use within 7 days of PICU admission
- Contraindication to azithromycin use including:
- History of pyloric stenosis
- Immunocompromised children (any cause)
- Current use of any medication known to cause QT prolongation
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 |
|---|---|---|
| Azithromycin 10 mgAlso: Zithromax, Z-Pak | Drug | Azithromycin (10 mg/kg) |
| Azithromycin 20mgAlso: Zithromax, Z-Pak | Drug | Azithromycin (20 mg/kg) |
| Placebo | Drug | Control |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline through Day 3
To determine the safety profile of AZM at 10 mg/kg and 20 mg/kg IV X 3 days in children with RSV-induced respiratory failure
Nasal Total Matrix Metalloproteinase (MMP)-9 Level
Time frame: Day 3
To determine the concentration of total MMP-9 levels in the nasal compartment
Pharmacokinetic-Plasma Half Life of AZM
Time frame: From baseline to 72 hours post treatment
Measurement of AZM half life in the plasma
Pharmacokinetic-Lung Half Life of AZM
Time frame: From baseline to 72 hours post treatment
Measurement of AZM half life in the lung
6 secondary outcomes
Duration of Mechanical Ventilation in Days
Time frame: Pre-treatment through 2 weeks
Duration of BiPAP in Days
Time frame: Pre-treatment through 2 weeks
Duration of High Flow Nasal Cannula in Days
Time frame: Pre-treatment through 2 weeks
Duration of Oxygenation in Days
Time frame: Pre-treatment through 2 weeks
Duration of Hospitalization in Days
Time frame: Pre-treatment through 2 weeks
Duration of PICU Stay in Days
Time frame: Pre-treatment through 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32324238Kong M, Zhang WW, Sewell K, Gorman G, Kuo HC, Aban I, Ambalavanan N, Whitley RJ. Azithromycin Treatment vs Placebo in Children With Respiratory Syncytial Virus-Induced Respiratory Failure: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e203482. doi: 10.1001/jamanetworkopen.2020.3482.
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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.
Michele Kong, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin 10 mg and Azithromycin 20mg in people with Respiratory Syncytial Virus, run by University of Alabama at Birmingham at 1 site in United States.
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 9 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 22 Jul 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: Baseline through Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707523, which also lists 1 linked publication.
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 22 Jul 2020.