NCT01592799 is a NA clinical trial of Throat swab and/or nasopharyngeal swab in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01592799?

NCT01592799 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01592799?

Interventions in NCT01592799: Throat swab and/or nasopharyngeal swab, Data collection.

Is NCT01592799 still recruiting?

NCT01592799 is currently completed. Last updated 27 July 2018.

Are results published for NCT01592799?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-07-27 · How we verify

NCT01592799

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain

Completed NA Results posted Last updated 27 July 2018

What this trial tests

NA trial testing Throat swab and/or nasopharyngeal swab in Influenza in 501 participants. Completed in 23 May 2011.

Timeline

23 November 2010

Primary endpoint
23 May 2011

23 May 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	501
Start date	23 November 2010
Primary completion	23 May 2011
Estimated completion	23 May 2011
Sites	1 location across Spain

Drugs / interventions tested

Throat swab and/or nasopharyngeal swab
Data collection — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Under 15, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever Primary · Day 0 till Day 28-37

ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.

Emergency Room

Group	Value	95% CI
Influenza Group	120

Hospitalized

Group	Value	95% CI
Influenza Group	11

Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Primary · Day 0 till Day 28-37

Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.

Laboratory

Group	Value	95% CI
Influenza Group	57.27	± 48.93

Radiology

Group	Value	95% CI
Influenza Group	16.94	± 9.68

Other diagnostics

Group	Value	95% CI
Influenza Group	89.94	± 80.25

Total for diagnostics

Group	Value	95% CI
Influenza Group	52.97	± 63.77

Prescribed medication [given in the hospital]

Group	Value	95% CI
Influenza Group	5.52	± 10.25

Prescribed medication

Group	Value	95% CI
Influenza Group	12.28	± 18.49

Non-prescribed medication

Group	Value	95% CI
Influenza Group	9.86	± 12.56

Total for treatments

Group	Value	95% CI
Influenza Group	16.44	± 21.68

Number of Subjects With Other Laboratory-confirmed Respiratory Viruses Secondary · Day 0 till Day 28-37

Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.

Emergency Room

Group	Value	95% CI
Influenza Group	98

Hospitalized

Group	Value	95% CI
Influenza Group	47

Number of Subjects With Fatal Outcomes Secondary · Day 0 till Day 28-37

Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	0

Number of Subjects With Secondary Bacterial Infections Secondary · Day 0 till Day 28-37

The outcome assessed the various complications by laboratory-confirmed influenza status.

Any complication

Group	Value	95% CI
Influenza Positive Group	37
Influenza Negative Group	145

Secondary bacterial pneumonia

Group	Value	95% CI
Influenza Positive Group	11
Influenza Negative Group	34

Primary influenza viral pneumonia

Group	Value	95% CI
Influenza Positive Group	3
Influenza Negative Group	7

Bronchiolitis

Group	Value	95% CI
Influenza Positive Group	10
Influenza Negative Group	67

Acute Otitis Media

Group	Value	95% CI
Influenza Positive Group	12
Influenza Negative Group	33

Myositis

Group	Value	95% CI
Influenza Positive Group	2
Influenza Negative Group	1

Pericarditis

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	0

Conjunctivitis

Group	Value	95% CI
Influenza Positive Group	3
Influenza Negative Group	16

Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Secondary · Day 0 till Day 28-37

Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.

Any pre-existing conditions

Group	Value	95% CI
Influenza Positive Group	32
Influenza Negative Group	82

No pre-existing conditions

Group	Value	95% CI
Influenza Positive Group	99
Influenza Negative Group	288

Prematurity (<36 weeks gestation)

Group	Value	95% CI
Influenza Positive Group	1
Influenza Negative Group	12

Chronic pneumopathy (including asthma)

Group	Value	95% CI
Influenza Positive Group	25
Influenza Negative Group	60

Cardiovascular disease

Group	Value	95% CI
Influenza Positive Group	1
Influenza Negative Group	2

Neuromuscular diseases

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	1

Other

Group	Value	95% CI
Influenza Positive Group	7
Influenza Negative Group	15

Breast fed

Group	Value	95% CI
Influenza Positive Group	15
Influenza Negative Group	88

Number of Days of Hospitalization Secondary · Day 0 till Day 28-37 (between October 2010 until May 2011)

The outcomes was assessed in subjects with laboratory-confirmed influenza status

Group	Value	95% CI
Influenza Positive Group	2.0	± 0.00
Influenza Negative Group	4.4	± 4.34

Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Secondary · Day 0 till Day 28-37

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Any medication

Group	Value	95% CI
Influenza Positive Group	119
Influenza Negative Group	300

Antibiotics

Group	Value	95% CI
Influenza Positive Group	9
Influenza Negative Group	21

Cough suppressants

Group	Value	95% CI
Influenza Positive Group	3
Influenza Negative Group	7

Antihistamines

Group	Value	95% CI
Influenza Positive Group	1
Influenza Negative Group	1

Pain medication

Group	Value	95% CI
Influenza Positive Group	12
Influenza Negative Group	21

Antipyretics

Group	Value	95% CI
Influenza Positive Group	114
Influenza Negative Group	267

Mucolytics

Group	Value	95% CI
Influenza Positive Group	1
Influenza Negative Group	5

Other medication

Group	Value	95% CI
Influenza Positive Group	10
Influenza Negative Group	61

Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Secondary · Day 0 till Day 28-37

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Any medication prescribed

Group	Value	95% CI
Influenza Positive Group	122
Influenza Negative Group	344

Antivirals

Group	Value	95% CI
Influenza Positive Group	4
Influenza Negative Group	1

Antibiotics

Group	Value	95% CI
Influenza Positive Group	17
Influenza Negative Group	77

Cough suppressants

Group	Value	95% CI
Influenza Positive Group	1
Influenza Negative Group	0

Pain medication

Group	Value	95% CI
Influenza Positive Group	12
Influenza Negative Group	28

Antipyretics

Group	Value	95% CI
Influenza Positive Group	120
Influenza Negative Group	284

Mucolytics

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	1

Other medication

Group	Value	95% CI
Influenza Positive Group	17
Influenza Negative Group	114

Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Secondary · Day 0 till Day 28-37

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Any medication prescribed

Group	Value	95% CI
Influenza Positive Group	130
Influenza Negative Group	367

Antivirals

Group	Value	95% CI
Influenza Positive Group	3
Influenza Negative Group	0

Antibiotics

Group	Value	95% CI
Influenza Positive Group	41
Influenza Negative Group	151

Cough suppressants

Group	Value	95% CI
Influenza Positive Group	6
Influenza Negative Group	3

Antihistamines

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	4

Pain medication

Group	Value	95% CI
Influenza Positive Group	7
Influenza Negative Group	18

Antipyretics

Group	Value	95% CI
Influenza Positive Group	121
Influenza Negative Group	287

Mucolytics

Group	Value	95% CI
Influenza Positive Group	3
Influenza Negative Group	9

Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Secondary · Day 0 till Day 28-37

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Any non-prescribed medication

Group	Value	95% CI
Influenza Positive Group	9
Influenza Negative Group	30

Antibiotics

Group	Value	95% CI
Influenza Positive Group	2
Influenza Negative Group	11

Antihistamines

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	1

Pain medication

Group	Value	95% CI
Influenza Positive Group	1
Influenza Negative Group	3

Antipyretics

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	2

Mucolytics

Group	Value	95% CI
Influenza Positive Group	0
Influenza Negative Group	1

Other medication

Group	Value	95% CI
Influenza Positive Group	6
Influenza Negative Group	16

Number of Days of School Absenteeism Secondary · Day 0 till Day 28-37

School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.

Group	Value	95% CI
Influenza Positive Group	6.6	± 3.46
Influenza Negative Group	6.4	± 3.66

Sponsor's own description

This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A prospective study to assess the burden of influenza-related hospitalizations and emergency department visits among children in Bilbao, Spain (2010-2011).
Ortiz-Lana N, Garrote E, Arístegui J, Rementeria J, et al · · 2017 · cited 1× · PMID 32289043 · DOI 10.1016/j.anpede.2017.01.002
[A prospective study to assess the burden of influenza-related hospitalizations and emergency department visits among children in Bilbao, Spain (2010-2011)].
Ortiz-Lana N, Garrote E, Arístegui J, Rementeria J, et al · · 2017 · cited 1× · PMID 28363360 · DOI 10.1016/j.anpedi.2016.10.016

Verify or expand the search:

Other recruiting trials for Influenza

Currently open trials in the same condition.

NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes · NA · recruiting
NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01592799 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 27 July 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01592799.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01592799

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Influenza

Other GlaxoSmithKline trials

Verify against primary sources