A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom

Table 1 Laboratory tests requested during hospitalization and follow-up

Procedures	HOSPITALIZATION			FOLLOW-UP
Procedures	Day 1	Day 2	Hospital discharge	Return 1 (R1) (10 days after discharge)	Return 2 (R2) (20 days after discharge)	Return 3 (R3) (30 days after discharge)
Application of FICT	X
Demographic data	X
Clinical history	X
Clinical exam	X	X	X	X	X	X
Concomitant medications	X	X	X	X	X	X
Adverse events	X	X	X	X	X	X
Vital signs	X^a	X	X	X	X	X
Hemogram	X	X	X	X	X	X
Urine type I	X^b	X	X	X	X	X
Urea	X	X	X	X	X	X
Creatinine	X	X	X	X	X	X
AST	X	X	X	X	X	X
ALT	X	X	X	X	X	X
Alkaline phosphatase	X	X	X	X	X	X
Gama GT	X	X	X	X	X	X
Bilirubin (direct)	X	X	X	X	X	X
Bilirubin (indirect)	X	X	X	X	X	X
Fasting blood sugar	X	X	X	X	X	X
Cholesterol (total and fractions)	X	X	X	X	X	X
Fibrinogen	X^b	X	X	X	X	X
C-reactive protein	X^b	X	X	X	X	X
ESR	X^b	X	X	X	X	X
PT	X^b	X	X	X	X	X
APTT	X^b	X	X	X	X	X
CPK	X^b	X	X	X	X	X
Albumin	X	X	X	X	X	X
Globulin	X	X	X	X	X	X
Pharmacokinetic profile	X^c	X	X	X	X	X
Proteomic profile	X^d	X	X	X	X	X
Pregnancy test	X^e

FICT free and informed consent term, AST aspartate aminotransferase, ALT alanine amino transferase, gama GT: gamma glutamyl transferase, CRP C-reactive protein, ESR erythrocyte sedimentation rate, PT prothrombin time, APTT activated partial thromboplastin time, CPK creatine phosphokinase
^aThe vital signs should be taken every 30 min during the infusion and every hour through the first 12 h after the infusion
^bCollect before and 12 h after termination of the infusion
^cEvaluate the profile and level of the antibodies IgG and IgM against the antivenom infusion (before and at 2, 6, 12 and 24 h after infusion)
^dEvaluate the profile of the different heterologous serum proteins in the antivenom (before and at 2, 6, 12 and 24 h after infusion)
^eIn special cases and at the investigator’s discretion this test could be repeated

ISSN: 1678-9199