SEVERE MALARIA
I.V. ARTESUNATE TREATMENT STUDY
CASE REPORTING FORM
For Belgium : Dr Jan Clerinx jclerinx@itg.be
Please send this form by mail - You may save the form on your computer for your own reference.
Name Clinic
Patient ID of local site:
……..
…….
Section 1 – Demographic and patient data
Date of presentation to clinic/hospital (format: dd-mm-yyyy)
Month/Year of birth (format: mm-yyyy)
Sex
Country of permanent residence
Patient Status
Country where infection was acquired
Chemoprophylaxis
Compliance
Purpose of travel
Pre-treatment criteria of severe
☐ Cerebral malaria or coma
malaria according to WHO
☐ Convulsions
definition
☐ Acute renal failure (urine output
(tick at least one):
<400/24h or creatine >2,5 mg/dl)
☐ Hyperparesitaemia (>10% of RBC or
>500 000/µl)
☐ Respiratory failure or ARDS
☐ Hypoglycaemia (<40 mg/dl)
☐ Circulatory collapse (Shock)
Significant pre-existing
comorbidities of the patient:
European resident/Immigrant
Yes/No
Yes/no
VFR/Tourism/Business/Other
☐ Spontaneous bleeding
☐ Acidosis (pH <7.25)
☐ Jaundice (bilirubin >3 mg/dl or >50µmol/l)
☐ ALAT/ASAT >3 x UNL
☐ anaemia (Hb <8 mg/dl)
☐ Hyperparesitaemia (>4% of RBC or
>200 000/µl) or
e.g. functional asplenism
Section 2 – Treatment regimen
First line Treatment? Yes/No
Date Day 1= Day of Dx and start of first line Tx (dd/mm/yy)
Administered anti-malarial
Start of
End of
Dosage per
substances
administration administration
dose (mg)
Drug 1:
Drug 2 :
Drug 3 :
Drug 4 :
Additional/supportive treatment/drugs:
If IV Artesunate is used, please specify
source of drug:
☐ MALACEF
☐ Other (specify)………………
Please specify batch No. and end of shelf life for i.v.
artesunate
Section 3 – Efficacy of treatment and
clinical outcome
Duration of inpatient ICU treatment
(days):
…….
Parasitemia at :
Baseline
6 hrs after 1st dose
12 hrs after 1st dose
24 hrs after 1st dose
36 hrs after 1st dose
% of RBC’s or parasites/µL
Parasitemia at:
48 hrs after 1st dose
60 hrs after 1st dose
72 hrs after 1st dose
% of RBC’s or parasites/µL
Time to parasitaemia <1 % (in hours):
Parasite clearance time (thick film) (in hours):
☐ None
Other:
☐ Mechanical ventilation
Specific supportive therapy
used:
☐ Haemodialysis
☐ Exchange transfusion
☐ Erythrocyte apheresis
☐ Vasopressor therapy
☐ Antibiotic therapy
☐ Transfusion of RBC
☐ Transfusion of clotting factors
☐ None
Other:
☐ Treatment failure (R I resistance)
☐ Bacterial superinfection/sepsis
☐ Circulatory collapse (Shock)
☐ Respiratory failure
Complications observed
during antimalaria
treatment:
☐ Pulmonary oedema
☐ Acute renal failure
☐ Coma
☐ Convulsions
☐ Metabolic acidosis (pH <7,25)
☐ Spontaneous bleeding
☐ Hypoglycaemia (<40mg/dl)
Outcome: ☐ Cure without sequellae
☐ Clinical improvement
☐ Exitus
(Day …..)
Outcome – details:
Follow-up: after 1st dose
Clinical/laboratory
abnormalities on follow-up
examination
Follow-up at day 7
Yes/No
Follow-up at day 14
Yes/No
Follow-up at day 28
Yes/No
☐ Direct or indirect signs of anaemia
or hemolysis
☐ day 7
☐ Abnormal liver function test
☐ Abnormal creatinine
☐ Neurologic abnormalities
☐day 14
☐ day 28
☐ day 14
☐ day 28
☐ day 14
☐ day 28
☐ day 14
☐ day 28
Adverse drug reaction suspected?
Screening for adverse drug reactions
Adverse drug
reaction
(Please, fill in:
name of the drug
+ adverse drug
reaction)
1.
2.
3.
4.
Day of
onset
Day of
cure
Day ≠
Day ≠
Yes/No
Severity at time point of
maximum intensity
Relation with drug
Mild, no
specific
medication
needed
Moderate,
specific
treatment
needed
Severe,
disabling or
lifethreatening
No
Possible Probable
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Further Comments (e.g. treatment of adverse drug reaction):
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