InfluenzaPhase 1NCT01033734

A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

A Phase 1 study testing oseltamivir [Tamiflu] in people with Influenza, run by Hoffmann-La Roche at 38 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 year to 12 years
Conditions the study is for: Influenza
What is being tested?: oseltamivir [Tamiflu]
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 38 sitesin 3 countries
Study dates: Dec 2010to Dec 2012
Phase: Phase 1
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 1 year to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

children, 1-12 years of age
diagnosis of influenza
duration of influenza symptoms </=96 hours prior to first dose of study drug

Who cannot join

evidence of severe hepatic decompensation
patients taking probenecid within 1 week prior to first dose of study drug

Trial locations and contacts

38 sites in 3 countries.

Country

City, postcode or hospital

38 sites in 3 countries

United States36 sites

Study site
Akron, Ohio, 44308
Study site
Aurora, Colorado, 80045
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02115
Study site
Boston, Massachusetts, 02118
Study site
Brooklyn, New York, 11203
Study site
Charleston, South Carolina, 29524
Study site
Chicago, Illinois, 60611
Study site
Cleveland, Ohio, 44106
Study site
Dayton, Ohio, 45404
Study site
Detroit, Michigan, 48201
Study site
Duluth, Minnesota, 55805
Study site
Durham, North Carolina, 27705
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida, 32209
Study site
Los Angeles, California, 90095
Study site
Louisville, Kentucky, 40202
Study site
Madison, Wisconsin, 53792
Study site
Morristown, New Jersey, 07960
Study site
New York, New York, 10016
Study site
Oakland, California, 94609-1809
Study site
Oklahoma City, Oklahoma, 73104
Study site
Omaha, Nebraska, 68131
Study site
Providence, Rhode Island, 02903
Study site
Raleigh, North Carolina, 27610
Study site
Richmond, Virginia, 23298
Study site
South Bend, Indiana, 46601
Study site
Springfield, Massachusetts, 01199
Study site
Stony Brook, New York, 11794-8161
Study site
Syracuse, New York, 13210
Study site
The Bronx, New York, 10461
Study site
Toledo, Ohio, 43606
Study site
Toledo, Ohio, 43608
Study site
Tyrone, Pennsylvania, 16686
Study site
Wichita, Kansas, 67214
Study site
Wilmington, Delaware, 19803

Other trials in United States

Israel1 site

Study site
Petah Tikva, 19202

Other trials in Israel

Lebanon1 site

Study site
Beirut, 11-236

Other trials in Lebanon

About this study

Official title: An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Conditions: Influenza
Being tested: oseltamivir [Tamiflu]
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oseltamivir [Tamiflu]Drug
5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.

Study groups in NCT01033734
Study group	Role	What they receive
Single arm	Experimental	Not described Receives: Drug: oseltamivir [Tamiflu]

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
Measured: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3
Measured: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4
Measured: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5
Measured: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2
Measured: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3
Measured: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4
Measured: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5
Measured: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

Secondary outcomes (7)

Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate
Measured: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values
IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.
Measured: Baseline, Day 1, 6 and 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Dec 2012

First posted16 Dec 2009 (estimated)
Study startDec 2010
Primary completionDec 2012
Study completionDec 2012

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 InfluenzaStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01033734
Sponsor's protocol ID: NP25139
Status last verified: Jul 2016
First submitted: 15 Dec 2009
Last updated: 24 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.
PubMed 26042486

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection
ClinicalTrials.gov ID: NCT01033734
Acronym / sponsor ID: NP25139
Conditions: Influenza
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 16 Dec 2009 (estimated)
Results: Posted 24 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm	Experimental	Drug: oseltamivir [Tamiflu]

Who may qualify

Ages: 1 year to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

children, 1-12 years of age
diagnosis of influenza
duration of influenza symptoms </=96 hours prior to first dose of study drug

Key exclusion criteria (2 listed)

evidence of severe hepatic decompensation
patients taking probenecid within 1 week prior to first dose of study drug

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
oseltamivir [Tamiflu]5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.	Drug	Single arm

Primary outcome

Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
Time frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3
Time frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4
Time frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5
Time frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2
Time frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3
Time frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4
Time frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5
Time frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

7 secondary outcomes

Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values
Time frame: Baseline, Day 1, 6 and 30

Results and safety

Results posted to the registry on 24 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oseltamivir: Overall	8	7

Primary outcome: Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1

Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanogram/milliliter (h*ng/mL)

Measure	Oseltamivir: 6 to 12 Years n = 1	Oseltamivir: 3 to 5 Years n = 3	Oseltamivir: 1 to 2 Years n = 0
Oseltamivir	829	1460 (46.3)	–
Oseltamivir Carboxylate	1700	4550 (61.1)	–

Population analysed: Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.

Primary outcome: AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2

Time frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Oseltamivir: 6 to 12 Years n = 0	Oseltamivir: 3 to 5 Years n = 1	Oseltamivir: 1 to 2 Years n = 1
Oseltamivir	–	1070	1920
Oseltamivir Carboxylate	–	5970	6760

Population analysed: PK population. Number of participants analyzed = participants who were evaluable for this outcome.

Primary outcome: AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3

Time frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion. Geometric mean (Geometric Coefficient of Variation). Unit: hr*ng/mL

Measure	Oseltamivir: 6 to 12 Years n = 1	Oseltamivir: 3 to 5 Years n = 0	Oseltamivir: 1 to 2 Years n = 0
Oseltamivir	943	–	–
Oseltamivir Carboxylate	2000	–	–

Population analysed: PK population. Number of participants analyzed = participants who were evaluable for this outcome.

Primary outcome: AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4

Time frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion. Geometric mean (Geometric Coefficient of Variation). Unit: hr*ng/mL

Measure	Oseltamivir: 6 to 12 Years n = 0	Oseltamivir: 3 to 5 Years n = 1	Oseltamivir: 1 to 2 Years n = 0
Oseltamivir	–	2480	–
Oseltamivir Carboxylate	–	3800	–

Population analysed: PK population. Number of participants analyzed = participants who were evaluable for this outcome.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oseltamivir: Overall	2 of 8 (25%)	5 of 8 (62.5%)	Not reported
Oseltamivir: 6 to 12 Years	1 of 2 (50%)	0 of 2 (0%)	Not reported
Oseltamivir: 3 to 5 Years	1 of 5 (20%)	4 of 5 (80%)	Not reported
Oseltamivir: 1 to 2 Years	0 of 1 (0%)	1 of 1 (100%)	Not reported

Limitations and caveats (from the sponsor): Low number of participants enrolled in the study at the time that the study was terminated limits conclusions that can be derived from the study data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26042486Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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.

Clinical Trials study director

Hoffmann-La Roche

38 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing oseltamivir [Tamiflu] in people with Influenza, run by Hoffmann-La Roche at 38 sites in 3 countries.

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 2 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 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Israel, Lebanon. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 24 Aug 2016). 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?

Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1 (time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.). The study lists 10 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 NCT01033734, 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 24 Aug 2016.