NCT02494219

Brief Summary

Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
906

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
Last Updated

July 10, 2015

Status Verified

June 1, 2015

Enrollment Period

2.9 years

First QC Date

June 18, 2015

Last Update Submit

July 7, 2015

Conditions

Pharyngitis

Keywords

Group A streptococcal pharyngitisRapid streptococcal testThroat swab culture

Outcome Measures

Primary Outcomes (1)

  • The ratio of true negative rapid immunochromatographic strep test when compared throat culture

    upto 48 hours

Secondary Outcomes (1)

  • The ratio of true positive rapid immunochromatographic strep test when compared to throat culture

    upto 48hours

Study Arms (1)

Rapid Immunochromatographic Streptococcal test

EXPERIMENTAL

Throat swabbing by two port germ Amines agar (copan) swabs,the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.

Procedure: Rapid Immunochromatographic streptococcal test

Interventions

Rapid Immunochromatographic streptococcal testPROCEDURE

Throat swab obtained for rapid strep test in addition to throat culture,in order to check the accuracy of Rapid Immunochromatographic streptococcal test in detection of streptococcal pharyngitis

Rapid Immunochromatographic Streptococcal test

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.

You may not qualify if:

  • Patients who received antibiotics within two weeks from presentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad medical corporation

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

July 10, 2015

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 10, 2015

Record last verified: 2015-06

Locations

QA(1)