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Table 1 Data Collection and Assessment Schedule

From: Single-dose liposomal amphotericin B (AmBisome®) for the treatment of Visceral Leishmaniasis in East Africa: study protocol for a randomized controlled trial

Assessments

In-patient assessment (day)

Follow-up (months)

 

BL

1

2,3,4,5

7

14

21

30

3

6

Clinical assessment (BP, body temperature, weight, height1, spleen size)

X

  

X

X

X

X

X

X

Haematology

(HB, WBC, Platelet)

X

  

X

X

X

X

X

X

Biochemistry2 (Urea, creatinine, ALT, AST, Na+, K+, Mg2+)

X

 

X

X

X

X

X

X

X

CARPA

X

X

 

X

X

    

Pharmacodynamic Assessment

X

 

X

X

X

 

X

X

X

Urinalysis (blood, protein, glucose)

X

 

X

X

X

X

X

  

Parasitology (splenic, LN, BM aspirates)3

X

     

X

X

X

HIV test

X

        

Electrocardiogram Examination4

X

  

X

X

X

X

 

X

Pregnancy test

X

        

Dosing - including monitoring of vital signs5

 

X

X

 

X

X

   

Adverse events6

X

X

X

X

X

X

X

X

X

  1. BL = Baseline, BP = blood pressure, HB = Haemoglobin, WBC = white blood cell count, AST = aspartate aminotransferase, ALT = Alanine transaminase, Na+= Sodium, K+ = Potassium, Mg2+ = Magnesium, CARPA = complement activation related pseudo allergy products, LN = lymph node, BM = bone marrow, HIV = Human immunodeficiency virus
  2. 1 Body height measurements on Day 0 only
  3. 2 Day 3 only
  4. 3 Parasitological investigations to be undertaken in the event of clinically significant abnormalities at 3 months follow-up
  5. 4 ECG if clinically indicated
  6. 5 Single-dose arm monitoring on day 1 only
  7. 6 Treatment emergent adverse events have onset at anytime between day 1 and day 60 for each patient
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Trials

ISSN: 1745-6215