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. 2015 Nov 23;2015(11):CD010481. doi: 10.1002/14651858.CD010481.pub2

Bodhe 2002.

Methods

  • Study design: open‐label parallel RCT

  • Study duration: NS
Participants

  • Setting: inpatients

  • Country: India

  • Health status: patients of any age or sex with clinically and radiologically suspected and histologically or microbiologically proven systemic fungal infection

  • Number (randomised/analysed): treatment group (20/17); control group (19/17)

  • Age (number of participants): age cut‐off was not defined in the study

    • Treatment group: adults (8); children (2); neonates (10)

    • Control group: adults (6); children (4); neonates (9)

  • Sex (M/F): treatment group (11/9); control group (10/9)

  • Exclusion criteria: pregnant women; moribund; other antifungal drugs co‐administered
Interventions Treatment group

  • Liposomal amphotericin B (L‐AMP‐LRC‐1)

    • Dose: 1 mg/kg

    • Duration: 3 to 8 weeks

    • Frequency: daily

    • Administration: IV, diluted with normal saline IP. 60 minutes infusion (three escalating doses were administered the first 3 days of therapy)


Control group

  • Conventional amphotericin B (Fungizone)

    • Dose: 1 mg/kg (a test dose of 1 mg administered over 20 to 30 minutes)

    • Duration: 3 to 8 weeks

    • Frequency: daily

    • Administration: IV, diluted with 5% dextrose over 2 to 6 hours
Outcomes

  • Infusion‐related reactions

    • Fever

    • Chills

    • Headache

    • Backache

    • Nausea

    • Vomiting

    • Palpitation

    • Apnoea

    • Tachypnoea

    • Dizziness

  • Nephrotoxicity (SCr level)
Notes

  • Support and financial assistance: Department of Biotechnology, Indian Government
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk No information on method included
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding of personnel and patients
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome data balanced between intervention groups (three in the intervention group and two in the control group)
Selective reporting (reporting bias) Low risk All pre‐specified outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement