Dutch Antibiotics in RSV infection Trial.

A randomized, double-blind, placebo-controlled trial on the efficacy of oral azithromycin for hospitalised children with respiratory syncytial virus lower respiratory tract disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22490

Enrollment

120

Registered

2005-08-24

Start date

2001-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RSV lower respiratory tract disease (bronchiolitis or pneumonia).

Interventions

Azithromycine 10 mg/kg/day for three days versus placebo.

Eligibility

Inclusion criteria

Inclusion criteria: Children 37.5° C), and/or cough, and/or coryza, and/or wheezing, and/or crackles on pulmonary auscultation.

Exclusion criteria

Exclusion criteria: Age >24 months, children presenting with apnoea with signs of lower respiratory tract disease, nosocomial RSV infection, antibiotic treatment less than 7 days before hospital admission, abscence of informed consent by parents or legal representatives.

Design outcomes

Primary

Measure	Time frame
Duration of hospitalisation.	—

Secondary

Measure	Time frame
1. Proportion and duration of oxygen therapy; 2. Proportion and duration of bronchodilator therapy; 3. Duration of tachypnoe (>40 breaths/min); 4. Duration of fever (> 37.5°C); 5. Duration of impaired feeding; 6. Number of infants referred to PICU Course of RSV score.	—

Contacts

Public ContactM.C.J. Kneyber

VU University Medical Center, Office 8 D 11, P.O. Box 7057

m.kneyber@vumc.nl+31 (0)20 4442413

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)