Case Reporting Form

SEVERE MALARIA

I.V. ARTESUNATE TREATMENT

CASE REPORTING FORM

For Belgium : Dr Jan Clerinx, Institute of Tropical Medicine ()

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 / M / F
Country of permanent residence
Patient Status / European resident/Immigrant
Country where infection was acquired
Chemoprophylaxis / Yes/No
Compliance / Yes/ No
Purpose of travel / VFR/Tourism/Business/Other
Pre-treatment criteria of severe malaria according to WHO definition
(tick at least one): / ☐ Hyperparesitaemia (>10% of RBC
or >500 000/µl)
☐ Hyperparesitaemia (>4% of RBC
or >200000/µl)
☐ Cerebral malaria (obnobulationor
coma)
☐ Convulsions
☐ Acute renal failure (urine output
<400/24h or creatine >2,5mg/dl)
☐ Respiratory failure or ARDS
☐ Circulatory collapse (Shock) / ☐ Anaemia (Hb <8 mg/dl)
☐ Very low platelet count (PLT < 20.000/ml)
☐ Spontaneous bleeding, DIC
☐ Hypoglycaemia (<40mg/dl)
☐ Acidosis (pH <7.25)
☐ Jaundice (bilirubin >3mg/dl or >50µmol/l)
☐ ALAT/ASAT >3x UNL
Significant pre-existing comorbidities of the patient (e.g. functional asplenism, HIV coinfection…)
Section 2 – Malaria 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 substances / Start of administration / End of administration / Dosage per 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)………………
Section 3 – Efficacy of treatment and clinical outcome / Duration of inpatient ICUtreatment (days):
Parasitemia %of RBC’s or parasites/µL
-Before treatment / Time to parasitemia < 1% (hours):
- 6hrs after 1stdose / Parasite clearance time (in hours):
-12hrs after 1stdose
-24hrs after 1stdose
-48hrs after 1stdose
-72hrs after 1stdose
Specific supportive therapy
☐ None
☐Mechanical ventilation
☐ Haemodialysis
☐ Exchange transfusion
☐ Erythrocyte apheresis
☐ Vasopressor therapy
☐ Antibiotic therapy
☐ Transfusion of RBC
☐ Transfusion of clotting factors / Complications during antimalaria treatment:
☐ None
☐ Treatment failure (R-1 resistance)
☐ Bacterial superinfection/sepsis
☐ Circulatory collapse (Shock)
☐ Respiratory failure
☐ Pulmonary oedema
☐ Acute renal failure
☐ Coma or Convulsions
☐ Metabolic acidosis (pH <7,25)
☐ Spontaneous bleeding or DIC
☐ Hypoglycaemia (<40mg/dl)
Outcome: ☐ Clinical and parasitological cure
☐ Clinical improvement (with sequellae, e.g. renal impairment)
☐ Death (N° days till death: ….. )
Outcome – details: / Follow-up at day 7
Follow-up at day 14
Follow-up at day 28 / Yes / No
Yes / No
Yes / No
Follow-up: after 1st dose / ☐Anaemia or hemolysis
☐Abnormal liver function test
☐Abnormal creatinine
☐Neurologic abnormalities / Yes / No
Yes / No
Yes / No
Yes / No
Other abnormalities on follow-up examination:
Screening for adverse drug reactions (severe anemia and other) / Adverse drug reaction suspected?
Yes/No
Adverse drug reaction
(Drug name + adverse drug reaction) / Day of onset
Day ≠ / Day of cure
Day ≠ / Severity of maximum intensity / Relation with drug
Mild, no specific medication needed / Moderate, specific treatment needed / Severe, disabling or life-threatening / No / Possible / Probable
☐ / ☐ / ☐ / ☐ / ☐ / ☐
☐ / ☐ / ☐ / ☐ / ☐ / ☐
☐ / ☐ / ☐ / ☐ / ☐ / ☐
☐ / ☐ / ☐ / ☐ / ☐ / ☐