Trial Outcomes & Findings for A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza (NCT NCT00949533)
NCT ID: NCT00949533
Last Updated: 2016-08-08
Results Overview
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
37 participants
Primary outcome timeframe
Day 5
Results posted on
2016-08-08
Participant Flow
Out of 199 participants, 162 were considered as screening failures, mainly due to the negative result detected by the quick test for Influenza A Antigen. Therefore, 37 participants included in the study.
Participant milestones
| Measure |
Standard Dose
Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter \[mg/mL\]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Standard Dose
Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter \[mg/mL\]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
Baseline characteristics by cohort
| Measure |
Standard Dose
n=19 Participants
Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
n=18 Participants
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.6 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
22.0 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
21.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5Population: ITT population. Here "number of participants analyzed" included evaluable participants for the outcome measure.
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
Outcome measures
| Measure |
Standard Dose
n=19 Participants
Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
n=17 Participants
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|---|---|---|
|
Percentage of Participants Excreting Resistant Virus
|
26.3 percentage of participants
|
35.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 5Population: ITT population.
Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load.
Outcome measures
| Measure |
Standard Dose
n=19 Participants
Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
n=18 Participants
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|---|---|---|
|
Percentage of Participants With A Reduction in Viral Load
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Population: ITT population. Here "number of participants analyzed" included evaluable participants for the outcome measure.
Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. "Other" in the category included abdominal pain, breathlessness, thoracic pain and tired.
Outcome measures
| Measure |
Standard Dose
n=19 Participants
Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
n=17 Participants
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|---|---|---|
|
Number of Participants With Various Clinical Signs and Symptoms
Cough
|
10 participants
|
9 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Rhinorrhea
|
10 participants
|
5 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Sore throat
|
2 participants
|
2 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Shortness of breath
|
2 participants
|
1 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Diarrhea
|
2 participants
|
0 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Headache
|
1 participants
|
2 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Conjunctivitis
|
1 participants
|
0 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Vomiting
|
1 participants
|
0 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms
Other
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 5Population: ITT population. Here "number of participants analyzed" included evaluable participants for the outcome measure.
Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category.
Outcome measures
| Measure |
Standard Dose
n=5 Participants
Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
n=6 Participants
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|---|---|---|
|
Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected
Cough
|
3 participants
|
4 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected
Rhinorrhea
|
3 participants
|
3 participants
|
|
Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected
Shortness of breath
|
0 participants
|
1 participants
|
Adverse Events
Standard Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Double Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Dose
n=19 participants at risk
Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
|
Double Dose
n=18 participants at risk
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal cramps
|
0.00%
0/19 • Up to 12 months
|
5.6%
1/18 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Up to 12 months
|
5.6%
1/18 • Up to 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Up to 12 months
|
5.6%
1/18 • Up to 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Up to 12 months
|
0.00%
0/18 • Up to 12 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
5.3%
1/19 • Up to 12 months
|
0.00%
0/18 • Up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Up to 12 months
|
5.6%
1/18 • Up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Up to 12 months
|
11.1%
2/18 • Up to 12 months
|
|
General disorders
Chest pain
|
0.00%
0/19 • Up to 12 months
|
5.6%
1/18 • Up to 12 months
|
|
General disorders
Feeling hot
|
0.00%
0/19 • Up to 12 months
|
5.6%
1/18 • Up to 12 months
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Up to 12 months
|
0.00%
0/18 • Up to 12 months
|
|
General disorders
Tracheobronchitis
|
5.3%
1/19 • Up to 12 months
|
0.00%
0/18 • Up to 12 months
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Up to 12 months
|
0.00%
0/18 • Up to 12 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/19 • Up to 12 months
|
5.6%
1/18 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Up to 12 months
|
0.00%
0/18 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Up to 12 months
|
0.00%
0/18 • Up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER