ClinicalTrials.gov
ClinicalTrials.gov Menu

Community Access to Rectal Artesunate for Malaria (CARAMAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03568344
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
UNITAID
UNICEF
Kinshasa School of Public Health
Akena Associates Ltd.
Clinton Health Access Initiative, USA
Makerere University
Information provided by (Responsible Party):
Swiss Tropical & Public Health Institute

Brief Summary:

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.


Condition or disease
Malaria

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 6032 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Community Access to Rectal Artesunate for Malaria (CARAMAL): Observational Research in Nigeria, Uganda and DR Congo
Estimated Study Start Date : June 15, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort
Community based tx seeking: baseline
Children <5 years of age seeking care for a current/recent febrile illness episode at the level of community based care providers in the study areas, including CHWs and primary health facilities during baseline period (no QA RAS administration).
tx seeking @ referral facility: baseline
Children <5 years of age seeking care for a severe febrile illness episode directly at the referral facility during baseline period (no QA RAS administration).
Community based tx seeking: Post RAS
Children <5 years of age seeking care for a current/recent febrile illness episode at the level of community based care providers in the study areas, including CHWs and primary health facilities after QA RAS roll-out (after pre-referral QA RAS administration).
tx seeking @ referral facility: Post RAS
Children <5 years of age seeking care for a severe febrile illness episode directly at the referral facility after QA RAS roll-out ( no QA RAS administration).



Primary Outcome Measures :
  1. Proportion of children <5 years with severe febrile illness seen by CHW/primary HF that resulted in death within 28 days [ Time Frame: From RAS administration up to 28 days ]
    Patient surveillance system (data collected at referral facility at 28 days visit including verbal autopsy)


Secondary Outcome Measures :
  1. Proportion of children <5 years with severe febrile illness without parasites on day 28 [ Time Frame: 28 days after RAS administration ]
    Rapid diagnostic test for malaria

  2. Proportion of children <5 years with a recent history of fever (mild or severe) who attend CHW/primary HF [ Time Frame: Through study completion, an average of 2 years ]
    Data obtained through Household surveys (semi-structured interviewer administered Treatment Seeking Questionnaire)

  3. Proportion of children <5 years with severe febrile illness seen by CHW/primary HF who completed referral [ Time Frame: From RAS administration up to 28 days ]
    Patient surveillance system (track patients from first point of contact at CHW or primary health facility until referral health facility)

  4. Number of children <5 years with severe febrile illness who report directly to referral health facility [ Time Frame: Through study completion, an average of 2 years ]
    Patient surveillance system (patients with severe febrile illness reporting directly to referral health facility)

  5. Proportion of children <5 years with severe febrile illness managed pre-referral according to guidelines [ Time Frame: Through study completion, an average of 2 years ]
    Patient surveillance system (data collected at CHW / primary HF)

  6. Proportion of children <5 years with severe febrile illness managed post-referral according to guidelines [ Time Frame: Through study completion, an average of 2 years ]
    Patient surveillance system (data collected at referral facility)

  7. Frequency of passively reported adverse events after RAS administration [ Time Frame: From RAS administration up to 28 days ]
    Continuous monitoring of patients medical records (referral facility) for adverse events

  8. Frequency of delayed haemolytic anaemia within 28 days after RAS administration [ Time Frame: 28 days after RAS administration ]
    Hemoglobin measurement

  9. Proportion of trained and functional CHW and primary HF who provide QA RAS [ Time Frame: Through study completion, an average of 2 years ]
    Data obtained through routine monitoring of process indicators along the entire case management chain to continuously assess implementation progress of RAS (Programmatic records)

  10. Proportion of CHW/primary HF with RAS in stock [ Time Frame: Through study completion, an average of 2 years ]
    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)

  11. Proportion of referral health facilities that have the capacity to manage severe malaria in children in line with global guidance [ Time Frame: Through study completion, an average of 2 years ]
    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)

  12. Proportion of CHW/primary HF that received at least one supervisory visit in the past 3 months [ Time Frame: Through study completion, an average of 2 years ]
    Data obtained through routine monitoring of process indicators (Programmatic records)

  13. Acceptability of pre-referral RAS among health workers [ Time Frame: Through study completion, an average of 2 years ]
    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)

  14. Acceptability of pre-referral RAS among caretakers [ Time Frame: Through study completion, an average of 2 years ]
    Qualitative data obtained through Household surveys (semi-structured interviewer administered Treatment Seeking Questionnaire including attitude towards RAS use)

  15. Total financial cost of managing severe case at community level. Marginal financial cost of adding RAS to the management [ Time Frame: From RAS administration up to 28 days ]
    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)

  16. Financial cost of RAS interventions per death averted [ Time Frame: Through study completion, an average of 2 years ]
    Incremental cost-effectiveness of QA RAS introduction over current standard of care for management of severe malaria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The PSS will include all children <5 years of age seeking care for a current/recent febrile illness episode at the level of community based care providers in the study areas, including CHWs and primary health facilities.

In addition, all children <5 years of age seeking care for a severe febrile illness episode directly at the referral facility will be enrolled to evaluate treatment seeking, diagnosis, treatment and disease outcome. These children will be excluded from the case fatality ratio analysis.

During baseline, RAS is expected not to be available at community level in the study area, and the PSS will enroll primarily children not treated with pre-referral RAS, whereas after RAS roll-out, RAS is expected to be administered at the level of community based health care providers.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568344


Contacts
Contact: Christian Burri, Prof +41 61 284 8961 christian.burri@swisstph.ch
Contact: Christian Lengeler, Prof +41 61 284 8221 christian.lengeler@swisstph.ch

Locations
Congo, The Democratic Republic of the
Kinshasa School of Public Health, University of Kinshasa Not yet recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Antoinette Tshefu, Prof    +243 81 015 6910    antotshe@yahoo.com   
Nigeria
Akena Associates Ltd.
Abuja, Nigeria
Uganda
Makerere University School of Public Health Not yet recruiting
Kampala, Uganda
Contact: Phyllis Awor, Dr    +256 712 651573    pawor@musph.ac.ug   
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
UNITAID
UNICEF
Kinshasa School of Public Health
Akena Associates Ltd.
Clinton Health Access Initiative, USA
Makerere University
Investigators
Principal Investigator: Christian Burri, Prof Swiss Tropical & Public Health Institute
Principal Investigator: Christian Lengeler, Prof Swiss Tropical & Public Health Institute

Additional Information:
Publications:
Responsible Party: Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03568344     History of Changes
Other Study ID Numbers: P 001-17-1.2
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Tropical & Public Health Institute:
Severe malaria
Mortality
Referral
Rectal artesunate
iCCM
Community based treatment

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials