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Table 1 Schedule of enrolment, interventions and assessments adapted from the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure

From: AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial

  Screening Week 1 Week 2 Week 4 Week 6 Week 8 Week 10 Week 16
Study day ≤D0 D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 D11 D12 D13 D14
Consent and randomisation
 Eligibility criteria X X                   
 PIS and signed consent X X                   
 Randomisation X X                   
Treatment
 Intervention: Ambisome 10 mg/kg   X                   
 Intervention: Fluconazole 1200 mg/day   X X X X X X X X X X X X X X      
 Intervention: Flucytosine 100 mg/kg/day   X X X X X X X X X X X X X X      
 Control: Amphotericin B deoxycholate 1 mg/kg   X X X X X X X             
 Control: Flucytosine 100 mg/kg/day   X X X X X X X             
 Control: Fluconazole 1200 mg/day          X X X X X X X      
 All participants: Fluconazole 800 mg/day                X X X X X  
 All participants: 200 mg/day                    X X
Clinical, safety and compliance assessment
 Inpatient clinical review   X X X X X X X X X X X X X X      
 Outpatient follow-up                 X X X X  
 Week 16 telephone                     X
Clinical labs
 HIV testing   X                   
 Pregnancy test (urine/serum)a   X                   
 Full blood count   X       X        X X     
 CD4 count   X                   
 ALT   X       X        X X     
 Urea, creatinine and electrolytes   X   X   X   X    X   X   X X     
 Drug levels   X       X             
 Quantitative PCR sub-study   X   X     X        X      
 Semi-quantitative cryptococcal antigen   X                   
CSF
 Opening pressure   X       X        X      
 Cell count and differentialb   X                   
 Protein, glucoseb   X                   
 Routine cultureb   X                   
 India ink examinationb,c   X                   
 Cryptococcal antigenb,c   X                   
 Quantitative fungal culture   X       X        X      
 CSF drug levels   X       X        X      
 Immune parameters   X       X        X      
 Semi-quantitative cryptococcal antigen   X                   
  1. aFor women of childbearing age; bPart of routine care; cIndia ink or cryptococcal antigen required for inclusion
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Trials

ISSN: 1745-6215