Trial Outcomes & Findings for Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon (NCT NCT01321216)

Results Overview

Incidence of rotavirus gastroenteritis associated hospitalization in children \< 5 years of age was 30.3% by PCR

Recruitment status

COMPLETED

Target enrollment

1555 participants

Primary outcome timeframe

2 years

Results posted on

2023-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Hospitalized Gastroenteritis Children under 5 years of age hospitalized with gastroenteritis
Overall Study STARTED	1555
Overall Study COMPLETED	1555
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hospitalized Gastroenteritis n=1555 Participants Children under 5 years of age hospitalized with gastroenteritis
Age, Continuous	22 Months n=1555 Participants
Sex: Female, Male Female	769 Participants n=1555 Participants
Sex: Female, Male Male	786 Participants n=1555 Participants
Region of Enrollment Lebanon	1555 Participants n=1555 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Children under 5 years of age hospitalized with gastroenteritis had a 30.3% rate of rotavirus infection

Incidence of rotavirus gastroenteritis associated hospitalization in children \< 5 years of age was 30.3% by PCR

Outcome measures

Outcome measures
Measure	Hospitalized Gastroenteritis n=1414 Participants Children under 5 years of age hospitalized with gastroenteritis
Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age	428 Participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Hospitalized Gastroenteritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ghassan Dbaibo

American University of Beirut

Phone: 961-1-350000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place