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prospective trial to evaluate the effect of nebulized vancomycin in children with cystic fibrosis

Role of nebulised vancomycin in the management of Staphylococcus aureus in children with cystic fibrosis: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025699
Enrollment
34
Registered
2020-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E840- Cystic fibrosis with pulmonary manifestations

Interventions

Intervention1: Nebulized vancomycin: Intervention will be given for a duration of 1 month Patient will receive nebulized vancomycin. Injectable form of vancomycin will be used.250 mg of vancomycin wil

Sponsors

Jagat Jeevan Ghimire
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children of cystic fibrosis with early Staphylococcus aureus infection.Early infection defined as a positive culture in current culture or culture within 6 months that was not treated on prior visits which may be either the first-lifetime positive culture or new emergence of the organism after at least 1 year of documented negative cultures

Exclusion criteria

Exclusion criteria: 1. Children with Current Co-colonisation with pseudomonas spp. 2. Children receiving anti-staphylococcal treatment in 4 weeks prior to screening and enrolment

Design outcomes

Primary

MeasureTime frame
Eradication of Staphylococcus aureus from the respiratory sampleTimepoint: 3 months

Secondary

MeasureTime frame
Adverse effect of antimicrobials therapyTimepoint: 3 months;Clinical ,nutritional ,radiologic severityTimepoint: 3 months;Number of hospital admissions and emergency visitsTimepoint: 3 months;Pattern of lung function testTimepoint: 3 months;Quality of life scoreTimepoint: 3 months

Countries

India

Contacts

Public ContactSushil Kumar Kabra

All India institute of medical sciences

skkabra@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026