Presenting symptoms and their duration in days Symptoms and
duration (days)
D0 D1 D2 D3 D4 D7 D14 D21 D28
Fever Headache Abdominal pain Vomiting
Diarrhea Poor appetite Cough
Absent: minus (-) [duration]
Present: plus (+) [duration]
If included: Year Serial number Treatment arm:
MP result:
If not included:
123 APPENDIX 2 CASE RECORD FORM 1
PARASITAEMIA (COUNT/ MICROLITRE) PATIENT ID……….
Day 0 1 2 3 7 8 - 13 14 15 -
20
21 28
Time of exam Temperature P. falciparum Asexual forms Gametocytes P. malariae Asexual forms Gametocytes P. ovale Asexual forms Gametocytes P. vivax Asexual forms Gametocytes Total
124 APPENDIX 3 CASE RECORD FORM 2
CLINICAL EXAMINATION FORM 1
Patients ID Patient’s name Treatment arm
Day of treatment Day 0 Day 1 Day 2 Day 3 Day 7
Date Time
Axillary temperature (oC) Haematocrit (%)
Weight (kg)
Cardio-respiratory System Heart rate/min
Respiratory rate/min Gastrointestinal Tract Abdominal distention Y/N Liver size (cm)
Spleen size (cm)
Central Nervous System General
(1) Awake (2) Drowsy (3)Unconscious (4) Agitated Muscle tone
(1) Normal (2) Hypotonia (3) Hypertonia
Other observations
Eyes: (1) Normal (2) Conjunctivitis (3) Others
Ears (1)Normal (2)Wax (3) Discharge (4)Hyperemic eardrum
Throat:(1)Normal (2) Pharyngitis (3)Tonsillitis (4)Other
Skin abnormalities (Y/N)
If Y, what? S. Scabies M. Measles P.
Papular O. Other Treatment given (Dose and Time)
125
APPENDIX 4
CASE RECORD FORM 3 CLINICAL ASSESSMENT OF ADVERSE REACTIONS TO DRUGS
Patient N0: …... Patient Name:………..
(Please fill Y/N except for day 0 where the duration is required) Symptoms
(Y/N)
Day / Date
Day 0 (duration)
1 2 3 4-6 7 8 - 13 14 15-20 21 22–27 28 35 42 42
Fever Vomiting Diarrhoea Anorexia Headache Abdominal pain Flatulence Drowsy Convulsion Tremor Weakness Dizziness Tinitus Deafness Visual impairment Palpitation Dry mouth Excessive salivation Itching Rash Sleeping difficulties Others Others
Miscellaneous observations or measurements
126 APPENDIX 5 CASE RECORD FORM 4
LABORATORY ASSESSMENT
Patient No (__ __ __ __ __ __) Day (_0__)
Haematology
WBC (__ __ ___ __)/mm3
% poly neutro (__ __)%
eosino (__ __)%
baso (__ __)%
%lympho (__ __)%
%monos (__ __)%
Platelets (__ __ __ _)/mm3 Haematocrit (__ __)%
PCR Sampling
Chemistry
Total Bilirubin (__ __ __ __) mmol/L ALT: (__ __ __ __) I.U/L
AST (__ __ __ __) I.U/L Creatinine (__ __ __ __) g/L
127 APPENDIX 6 CASE RECORD FORM 5 TREATMENT AND MONITORING SHEET.
Patient ID………
ADMINISTRATIONS Day 0
Day 1
Day 2
Day of failure
Retreatment day 0
Retreatment day 1
Retreatment Day 2 Exact time (hh/mm)
No of Tablets
128 APPENDIX 7
INVESTIGATIONAL PRODUCTS (IPs) INFORMATION Artemether-lumefantrine (AL) 20/120mg
Batch N0: F 1157
Manufacture date: 04/2009 Expiry date: 07/2011.
Artesunate-amodiaquine (AA) 25mg/67.5mg Batch N0: 1012
Manufacture date: 04/2009 Expiry date: 04/2011.
Artesunate-amodiaquine 50/135mg Batch N0: 3017
Manufacture date: 04/2009 Expiry date: 04/2011
129 APPENDIX 8
Consent information / Confidentiality and other ethical considerations
I DR. Shwe, David Danjuma of the Department of Paediatrics, JUTH is conducting a study to make sure that the antimalarial drug combinations artemether-lumefantrine and artesunate -amodiaquine recommended for the management of simple Falciparum malaria are effective and safe.
If you agree for your child to participate in the study, I will ask you some questions and take a finger prick blood specimen from your child to determine if he or she meets the criteria for enrolment. The amount of blood taken will be in drops daily and 5ml blood at enrolment, days 3 and 7. The blood will be tested for malaria and other important parameters. The doctor will use his experience to reduce the pain from finger prick to the barest minimum.
If your child has malaria, meets other criteria for enrolment and you agree, I will give your child one or two drugs as treatment for malaria. I will ask you to bring your child to the clinic for 4 days in a row, and on the 14th, 21st and 28th day after enrolment. On each of these visits, I will take a finger prick blood specimen to determine if malaria is present. If your child becomes ill, you should bring the child to the clinic even if no appointment is scheduled. You will be reimbursed for travel to and from the clinic.
The tests and the examination will be done for free. If your child develops a fever and has malaria, I will treat him or her as required and follow-up the child until malaria parasites are cleared from the blood.
This study is completely voluntary. If you do not want to join the study you and your child will still receive routine care here at the clinic. If you join the study, but then decide you want to stop participating, you may withdraw from the study. If you do withdraw from the study, your child and your family are still welcome to use the clinic and are encouraged to come if you become ill.
If you agree to participate, your child will benefit from the closer follow-up than would ordinarily be available.
130
Child's (Initials) ________________. Today’s date: _____________________
DD MM YYYY
Mother's/Caregiver’s statement (check one)
( ) The above study has been explained to me and I agree to participate and have my child participate. I understand that this is a voluntary study, that if I change my mind, that my child and I will continue to receive medical care.
Mother's/Caregiver’s signature (or mark of consent) _______________
Date _________________________________
DD MM YYYY
Witness’s name & signature or mark _______________________
Date _________________________________
( ) The above study has been explained to me and I do not want myself or my child to participate. I understand that this is a voluntary study and that my child will continue to receive care even though I have decided not to be in the study.
Please indicate the reason this person did not want to participate: ___________________
________________________________________________________________________
Investigator’s signature _____________________________________________
Date ___________________
131
4.0. CONFIDENTIALITY AND OTHER ETHICAL CONSIDERATION
Full confidentiality usually accorded patient’s records was operative. The recruitment form bore the name of the patient and this is in the custody of the principal investigator (PI) for purposes of data collection. Any adverse events observed or reported in the NAFDAC’s pharmacovigilance form, duly reported to the JUTH pharmacovigilant unit and managed by the investigator at no cost to the participants. The hosting community benefitted from the improved care that was mandatory for the study and the awareness created for care seeking and compliance.