Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317590
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2006-04-23
Brief Title:
Effectiveness and Cost-Effectiveness of a Rapid Diagnostic Test for Malaria
Sponsor:
Centro per le Malattie Tropicali
Organization:
Centro per le Malattie Tropicali
Study Overview
Official Title:
Evaluation de lutilité et du coût-efficacité du Test Rapide Paracheck Pour la Prise en Charge Des Cas de Paludisme Dans Les régions Des Hauts Bassins et Des Cascades au Burkina Faso
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is increasing evidence from African countries including Burkina Faso that at least in some settingsseasons the proportion of fevers attributable to malaria is low or very low this means that the current strategy of treating all fever cases as malaria is only to the advantage of very few Rapid antigenic tests might be of help particularly in peripheral health centres such as the Centres de Santé et Promotion Sociale CSPS that lack any laboratory facilities Nevertheless two major problems could arise
False negatives as only the negative result would change the decision to treat versus the current presumptive strategy false negatives would not be treated for malaria
False positives they would be exposed to the risk to be left without treatment for the true cause of their fever instead
The main purpose of this study is to assess if the short term outcome of febrile patients treated after testing with the Rapid Diagnostic Test Paracheck is at least equivalent not inferior to that of controls presumptively treated without any test in terms of clearance of fever and other major symptoms and signs
To do so febrile patients will be randomly assigned to be submitted to the test before clinical decision or to be managed the usual way with no test A follow up will be carried out at Day 4th in order to determine the proportion of patients in both groups with persistence of fever and other main clinical symptoms
False negatives as only the negative result would change the decision to treat versus the current presumptive strategy false negatives would not be treated for malaria
False positives they would be exposed to the risk to be left without treatment for the true cause of their fever instead
The main purpose of this study is to assess if the short term outcome of febrile patients treated after testing with the Rapid Diagnostic Test Paracheck is at least equivalent not inferior to that of controls presumptively treated without any test in terms of clearance of fever and other major symptoms and signs
To do so febrile patients will be randomly assigned to be submitted to the test before clinical decision or to be managed the usual way with no test A follow up will be carried out at Day 4th in order to determine the proportion of patients in both groups with persistence of fever and other main clinical symptoms
Detailed Description:
Primary outcome proportion of cases fever patients randomised to be submitted to the rapid test before treatment and controls fever patients randomised not to be submitted to the rapid test with persisting fever at follow-up
Secondary outcomes
proportion of cases fever patients randomised to be submitted to the rapid test before treatment and controls fever patients randomised not to be submitted to the rapid test with persistingnew major clinical symptomssigns andor clinical complications at follow-up
proportion of cases and controls referred to hospital
prevalence of malaria infection among febrile and not febrile patients
attributable fraction AF of fever episodes to malaria infection as established by subsequent microscopic examination of blood slide and determination of the parasitemia level
optimal cut-off level of parasitemiatreatment threshold in order to define a case of malaria disease vs a simple malaria infection ie presence of malaria parasites in the blood but presumably not the cause of fever
performances of Paracheck sensitivity specificity and predictive values on malaria disease in the field compared with expert reading
proportion of cases and controls with malaria disease that have not been treated with antimalarialshave been treated for other presumed causes of fever
proportion of cases and controls without malaria disease that have been treated with antimalarials have not been treated for other presumed causes of fever
proportion of cases and control receiving any other treatment at enrolment andor at follow up
Cost - effectiveness models will take into account all costs involved in diagnosis and treatment both for malaria and other conditions
Sample size Sample size is determined for the main clinical outcome under study that is fever clearance Expected freq of fever persistence at day 4th 40 maximal accepted difference 10 power of study 90 alpha error 5 sample size 814 We plan to enrol at least 500 subjects with fever per arm in both seasons in order to account for loss to follow up
Expected total enrolment 4000 1000 fever cases and 1000 patients without fever in each study period Only fever patients will be randomised to be submitted or not to the rapid test Patients without fever will be consecutively enrolled and submitted to malaria slides and clinical questionnaire but not to the rapid test
Study start 24th April 2006
Second Phase 2nd October 2006
In each study period at the end of the dry season and the end of the rainy season for up to to three weeks in each study period all patients 6 months presenting for clinical consultation at one of the 10 peripheral health centres participating in the study responding to inclusion criteria and consenting to participatewith parental consent to participate will be enrolled All will be submitted free of charge to a thick film and a thin film for malaria and a brief questionnaire on clinical history All slides will be stored for further reading Those patients with fever at presentation axillary temperature 375C will be randomised based on computer-generated random number lists either to be submitted to a Paracheck rapid test for malaria cases or to be managed the usual way that is on clinical grounds alone controls Only Paracheck result will be used for decision on malaria treatment for cases Treatment of controls and treatment of any other condition for both cases and controls will solely depend on the judgment of the clinical officer No other formal algorithm will be followed than the national guidelines
Sensitisation of the study sites and information to the public has been carried out before the start of the intervention A detailed information about the study purposes and implications will be provided to all patients attending the clinical consultation and witnessed signed informed consent will be obtained
Inclusion criteria All patients 6 months presenting to clinical consultation and consenting to participatewith parental consent to participate
Exclusion criteria Refusal to participate Severe clinical conditions with emergency treatment needed as judged by the clinical officer Pregnancy not an exclusion criterion
Follow-up This will be carried out ad Day 4th after recruitment for fever patients only The following main outcomes will be determined at follow-up
1 Durationclearance of fever time of fever clearance
2 Durationclearance of other clinical symptomssigns registered at entry
3 Appearance of new clinical symptomssigns including danger signs according to a checklist
4 Patients submitted to new modified treatment
5 Patients needing referral to hospital
6 Deaths
Secondary outcomes
proportion of cases fever patients randomised to be submitted to the rapid test before treatment and controls fever patients randomised not to be submitted to the rapid test with persistingnew major clinical symptomssigns andor clinical complications at follow-up
proportion of cases and controls referred to hospital
prevalence of malaria infection among febrile and not febrile patients
attributable fraction AF of fever episodes to malaria infection as established by subsequent microscopic examination of blood slide and determination of the parasitemia level
optimal cut-off level of parasitemiatreatment threshold in order to define a case of malaria disease vs a simple malaria infection ie presence of malaria parasites in the blood but presumably not the cause of fever
performances of Paracheck sensitivity specificity and predictive values on malaria disease in the field compared with expert reading
proportion of cases and controls with malaria disease that have not been treated with antimalarialshave been treated for other presumed causes of fever
proportion of cases and controls without malaria disease that have been treated with antimalarials have not been treated for other presumed causes of fever
proportion of cases and control receiving any other treatment at enrolment andor at follow up
Cost - effectiveness models will take into account all costs involved in diagnosis and treatment both for malaria and other conditions
Sample size Sample size is determined for the main clinical outcome under study that is fever clearance Expected freq of fever persistence at day 4th 40 maximal accepted difference 10 power of study 90 alpha error 5 sample size 814 We plan to enrol at least 500 subjects with fever per arm in both seasons in order to account for loss to follow up
Expected total enrolment 4000 1000 fever cases and 1000 patients without fever in each study period Only fever patients will be randomised to be submitted or not to the rapid test Patients without fever will be consecutively enrolled and submitted to malaria slides and clinical questionnaire but not to the rapid test
Study start 24th April 2006
Second Phase 2nd October 2006
In each study period at the end of the dry season and the end of the rainy season for up to to three weeks in each study period all patients 6 months presenting for clinical consultation at one of the 10 peripheral health centres participating in the study responding to inclusion criteria and consenting to participatewith parental consent to participate will be enrolled All will be submitted free of charge to a thick film and a thin film for malaria and a brief questionnaire on clinical history All slides will be stored for further reading Those patients with fever at presentation axillary temperature 375C will be randomised based on computer-generated random number lists either to be submitted to a Paracheck rapid test for malaria cases or to be managed the usual way that is on clinical grounds alone controls Only Paracheck result will be used for decision on malaria treatment for cases Treatment of controls and treatment of any other condition for both cases and controls will solely depend on the judgment of the clinical officer No other formal algorithm will be followed than the national guidelines
Sensitisation of the study sites and information to the public has been carried out before the start of the intervention A detailed information about the study purposes and implications will be provided to all patients attending the clinical consultation and witnessed signed informed consent will be obtained
Inclusion criteria All patients 6 months presenting to clinical consultation and consenting to participatewith parental consent to participate
Exclusion criteria Refusal to participate Severe clinical conditions with emergency treatment needed as judged by the clinical officer Pregnancy not an exclusion criterion
Follow-up This will be carried out ad Day 4th after recruitment for fever patients only The following main outcomes will be determined at follow-up
1 Durationclearance of fever time of fever clearance
2 Durationclearance of other clinical symptomssigns registered at entry
3 Appearance of new clinical symptomssigns including danger signs according to a checklist
4 Patients submitted to new modified treatment
5 Patients needing referral to hospital
6 Deaths
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None