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Effect of oral melatonin in critically ill sepsis patients

Effect of enteral melatonin on invasive fungal infection and antifungal susceptibility profile in critically ill sepsis patients: A prospective randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078819
Enrollment
120
Registered
2024-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: B377- Candidal sepsis Health Condition 2: B440- Invasive pulmonary aspergillosis Health Condition 3: B460- Pulmonary mucormycosis Health Condition 4: A403- Sepsis due to Streptococcus pneumoniae Health Condition 5: A410- Sepsis due to Staphylococcus aureus Health Condition 6: A413- Sepsis due to Hemophilus influenzae Health Condition 7: A415- Sepsis due to other Gram-negativeorganisms Health Condition 8: A419- Sepsis, unspecified organism

Interventions

Intervention1: enteral melatonin in critically ill patients: 20mg of melatonin in form of 4 doses of 5mg tablets given every 1hourly starting from 9pm through ryles tube Control Intervention1: placeb

Sponsors

Addetlla Sravani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. patients admitted to ICU within 2 days of hospital admission 2.patients with suspected risk of infections 3.patients with anticipated ICU stay of more than 5 days

Exclusion criteria

Exclusion criteria: 1.Patients known to be pregnant 2.Patients having allergy to study drug 3.receiving palliative care or not expected to survive more than 12 hrs 4.patients receiving any anticoagulant therapy 5.known to have received another interventional trial that might interact with study drug

Design outcomes

Primary

MeasureTime frame
1.Incidence of invasive fungal infections 2.Susceptibility profile in form of MIC values of antifungal agents Timepoint: Day 1 of ICU admission Day 5 Day 7 Day 10 Day 14 Day 28

Secondary

MeasureTime frame
1.total days of free antifungal therapy 2.Incidence of bacterial sepsis and septic shock 3.susceptibility profile of bacterial agents 4.ventilator free days 5.length of ICU stay 6.Outcome (sepsis and septic shock, deathTimepoint: throughout the 28days of ICU stay or till death, which ever is earlier

Countries

India

Contacts

Public ContactDrMunesh kumar Gupta

Institute of medical sciences, Banaras Hindu University

badriprasad.dash5@gmail.com9415214623

Outcome results

None listed

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