Malaria Clinical Trial
— CARAMALOfficial title:
Community Access to Rectal Artesunate for Malaria (CARAMAL): Observational Research in Nigeria, Uganda and DR Congo
NCT number | NCT03568344 |
Other study ID # | P 001-17-1.2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2018 |
Est. completion date | August 31, 2021 |
Verified date | January 2021 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Many malaria deaths occur in places where people have poor access to preventive and curative health services. Prompt access to quality health services is critical in the case of severe childhood diseases, among which severe malaria is particularly frequent in endemic areas. In communities where parenteral treatment of severe malaria is not available, the World Health Organization (WHO) recommends administration of a single rectal dose of artesunate (RAS) to children less than 6 years, followed by immediate referral to an appropriate facility where the full package of care for severe malaria can be provided. Many African countries have already endorsed the use of pre-referral RAS. But treatment guidelines vary widely across these countries and often do not align with the WHO recommendation. With the impending availability of quality-assured rectal artesunate (QA RAS) and countries poised to scale-up this intervention, it is critical to investigate the safe and effective implementation of RAS as part of a continuum of care for severe malaria patients. To ensure that RAS is well targeted, it is equally urgent to learn more about frequency, treatment seeking and risk factors for severe malaria at community level. The CARAMAL project has two major components: the pilot implementation of QA RAS in selected areas of the Democratic Republic of the Congo (DRC), Nigeria and Uganda, and operational research on the introduction of QA RAS into established integrated community case management (iCCM) platforms. The CARAMAL project is funded by Unitaid and coordinated by the Clinton Health Access Initiative, Inc. (CHAI). UNICEF is responsible for QA RAS implementation. Swiss TPH in partnership with the local research organizations Akena Associates Ltd. in Nigeria, Kinshasa School of Public Health in DRC and Makerere University School of Public Health in Uganda carries out the operational research component to generate evidence for the responsible implementation of RAS. Finally, the CARAMAL project will generate a better understanding of severe febrile illness, its management at all levels and key determinants of health outcomes.
Status | Completed |
Enrollment | 13758 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 59 Months |
Eligibility | Inclusion Criteria: - Patient surveillance system: - Children < 5 years - History of fever plus danger signs indicative of severe febrile illness / suspected severe malaria, according to local iCCM guidelines - Child referred to higher level facility by CHW/primary health facility, or, child directly attending a referral facility. Signed full consent form from parent / guardian Health care provider interview: - CHW or health worker at peripheral health facility enrolled in the iCCM referral system who treats children < 5 years OR - Health care provider at referral hospitals treating children < 5 years OR - Any other health care provider in project area treating children < 5 years - Signed consent form Household survey: - Household head and parent / caregiver of children < 5 years - Signed consent form from parent / guardian Exclusion Criteria: - Patient surveillance system: - Children = 5 years - Children with no permanent residence in project area Health care provider interview: - Health workers not treating children < 5 years - Health workers outside project area - Health workers who do not speak any of the local languages - Health workers employed since < 1 month Household survey: - Parents / guardians with no children < 5 years - Parents / guardians with no permanent residence in project area - Parents / guardians who do not speak any of the local languages |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Kinshasa School of Public Health, University of Kinshasa | Kinshasa | |
Nigeria | Akena Associates Ltd. | Abuja | |
Uganda | Makerere University School of Public Health | Kampala |
Lead Sponsor | Collaborator |
---|---|
Swiss Tropical & Public Health Institute | Akena Associates Ltd., Clinton Health Access Initiative Inc., Kinshasa School of Public Health, Makerere University, UNICEF, UNITAID |
Congo, The Democratic Republic of the, Nigeria, Uganda,
Gomes MF, Faiz MA, Gyapong JO, Warsame M, Agbenyega T, Babiker A, Baiden F, Yunus EB, Binka F, Clerk C, Folb P, Hassan R, Hossain MA, Kimbute O, Kitua A, Krishna S, Makasi C, Mensah N, Mrango Z, Olliaro P, Peto R, Peto TJ, Rahman MR, Ribeiro I, Samad R, White NJ; Study 13 Research Group. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet. 2009 Feb 14;373(9663):557-66. doi: 10.1016/S0140-6736(08)61734-1. Epub 2008 Dec 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children <5 years with severe febrile illness seen by CHW/primary HF that resulted in death within 28 days | Patient surveillance system (data collected at referral facility at 28 days visit including verbal autopsy) | From RAS administration up to 28 days | |
Secondary | Proportion of children <5 years with severe febrile illness without parasites on day 28 | Rapid diagnostic test for malaria | 28 days after RAS administration | |
Secondary | Proportion of children <5 years with a recent history of fever (mild or severe) who attend CHW/primary HF | Data obtained through Household surveys (semi-structured interviewer administered Treatment Seeking Questionnaire) | Through study completion, an average of 2 years | |
Secondary | Proportion of children <5 years with severe febrile illness seen by CHW/primary HF who completed referral | Patient surveillance system (track patients from first point of contact at CHW or primary health facility until referral health facility) | From RAS administration up to 28 days | |
Secondary | Number of children <5 years with severe febrile illness who report directly to referral health facility | Patient surveillance system (patients with severe febrile illness reporting directly to referral health facility) | Through study completion, an average of 2 years | |
Secondary | Proportion of children <5 years with severe febrile illness managed pre-referral according to guidelines | Patient surveillance system (data collected at CHW / primary HF) | Through study completion, an average of 2 years | |
Secondary | Proportion of children <5 years with severe febrile illness managed post-referral according to guidelines | Patient surveillance system (data collected at referral facility) | Through study completion, an average of 2 years | |
Secondary | Frequency of passively reported adverse events after RAS administration | Continuous monitoring of patients medical records (referral facility) for adverse events | From RAS administration up to 28 days | |
Secondary | Frequency of delayed haemolytic anaemia within 28 days after RAS administration | Hemoglobin measurement | 28 days after RAS administration | |
Secondary | Proportion of trained and functional CHW and primary HF who provide QA RAS | Data obtained through routine monitoring of process indicators along the entire case management chain to continuously assess implementation progress of RAS (Programmatic records) | Through study completion, an average of 2 years | |
Secondary | Proportion of CHW/primary HF with RAS in stock | Data obtained through routine monitoring of process indicators (Programmatic records) and Health care provider surveys (structured checklist to assess the availability of essential medical supplies (incl. RAS) and equipment, human resource capacity, infrastructure and documentation) | Through study completion, an average of 2 years | |
Secondary | Proportion of referral health facilities that have the capacity to manage severe malaria in children in line with global guidance | Data obtained through routine monitoring of process indicators (Programmatic records) and Health care provider surveys (structured checklist to assess the availability of essential medical supplies (incl. RAS) and equipment, human resource capacity, infrastructure and documentation and interviewer administered questionnaires to assess the health worker's demographics, education and training, work experience and supervision, type and utility of any work-related training received, knowledge, attitudes and practices relevant to febrile case management (incl. diagnostic algorithm and (RAS) treatment guidelines) and intermittent preventive treatment in infants and pregnancy (IPTi, IPTp), experiences implementing malaria/febrile case management and prevention guidelines) | Through study completion, an average of 2 years | |
Secondary | Proportion of CHW/primary HF that received at least one supervisory visit in the past 3 months | Data obtained through routine monitoring of process indicators (Programmatic records) | Through study completion, an average of 2 years | |
Secondary | Acceptability of pre-referral RAS among health workers | Qualitative data obtained through Health care provider surveys (interviewer administered questionnaires to assess the health worker's demographics, education and training, work experience and supervision, type and utility of any work-related training received, knowledge, attitudes and practices relevant to febrile case management (incl. diagnostic algorithm and (RAS) treatment guidelines) and intermittent preventive treatment in infants and pregnancy (IPTi, IPTp), experiences implementing malaria/febrile case management and prevention guidelines) | Through study completion, an average of 2 years | |
Secondary | Acceptability of pre-referral RAS among caretakers | Qualitative data obtained through Household surveys (semi-structured interviewer administered Treatment Seeking Questionnaire including attitude towards RAS use) | Through study completion, an average of 2 years | |
Secondary | Total financial cost of managing severe case at community level. Marginal financial cost of adding RAS to the management | Costs extracted from the routine accounting documents of the iCCM projects in the three countries, Health care providers surveys and costs incurred by caretakers during referral (PSS Day 28 assessment) | From RAS administration up to 28 days | |
Secondary | Financial cost of RAS interventions per death averted | Incremental cost-effectiveness of QA RAS introduction over current standard of care for management of severe malaria | Through study completion, an average of 2 years |
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