MalariaNCT00115921
Evaluation of Home-Based Management of Fever in Urban Ugandan Children
A study testing Provision of antimalarial treatment at home in people with Malaria and Anemia, run by London School of Hygiene and Tropical Medicine.
Trial summary
The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- What is being tested?
- Provision of antimalarial treatment at home
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1 - 5 years
- Agreement of parents or guardians to provide informed consent
- Live in Mulago III Parish
Who cannot join
- History of any known serious chronic disease requiring frequent medical care (e.g. AIDS, sickle cell disease, malignancy)
- Intention to move from Kampala during the 13 month follow-up period
- History of serious side effects to study medications
- Weight < 10 kg
- Severe malnutrition defined as a weight-for-height or height-for-age Z-score < - 3
About this study
The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.
Read the detailed description
Population: Representative sample of Ugandan children aged 1 to 5 years from 400 households (approximately 540 children).
Clinical Site: The study will be conducted in the Mulago III parish community of Kampala, Uganda.
Study Duration: 13 months
Study Intervention: *Pilot period: After enrollment, households will participate in a one month pilot period to test the household pictorial diaries. At the end of the pilot period, households will be randomized to participation in the home-based management of fever (HBMF) arm or standard care arm for the remainder of the study (12 months). *HBMF arm: Households randomized to the HBMF group will be provided with pre-packaged coartemether to keep at home. Primary caregivers will be instructed to treat children participating in the study empirically with coartemether at home when the child develops fever. Study personnel will distribute drugs and educate the caregivers about administration of drugs, recognition of danger signs of fever/malaria, and when to seek additional care. *Standard care: Households randomized to the standard care arm will be asked to continue their current behaviour and to manage fever in their children as they would normally.
Measurements: Household diaries and monthly visits. Primary caregivers will be asked to keep a diary regarding the health of study participants for the duration of the study (13 months). Information on illnesses, treatments given, visits to health care facilities, and health care expenditures will be collected. Study personnel will visit the households monthly to collect completed diaries. At each visit, questionnaires will be administered to gather additional data on the health of the participants and treatment seeking behaviour.
Clinical and laboratory evaluations: Temperature, height, weight, mid-upper arm circumference, spleen size, haemoglobin, and thick blood smear will be assessed at enrollment, and at the beginning and end of the intervention period.
Study Objectives: 1. To measure the impact of home-based management of fever with coartemether on malaria-related morbidity compared to the current standard of care in the community.
- To measure the impact of home-based management of fever with coartemether on economic measures compared to the current standard of care in the community.
Primary outcome: Treatment incidence density (treatments per time at risk) for each treatment arm
Secondary clinical outcomes: 1) mean days of fever; 2) incidence of febrile episodes; 3) mean haemoglobin at study end; 4) change in mean haemoglobin; 5) prevalence of splenomegaly; 6) prevalence of parasitaemia; 7) incidence of visits to health care facilities, and hospitalizations; 8) mortality rate; 9) anthropometric measurements; 10) proportion of "appropriate" treatments; 11) proportion of delayed treatments; 12) treatment incidence density of treatments given at >50% and at full dose
Economic outcomes: 1) household cost/febrile episode; 2) household costs for treatment of febrile episode/month; 3) provider cost/child for delivery of HBMF; 4) estimated provider facility cost/patient for uncomplicated fever, and for severe disease; 5) total net cost/child/year; 6) net cost/additional child appropriately treated; 7) net cost/day of fever averted
- Being tested
- Provision of antimalarial treatment at home
- Keywords
- Home-based care, Malaria, Africa
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of antimalarial treatment at homeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.
Secondary outcomes (7)
Mean days of fever per participant
Incidence of febrile episodes
Mean haemoglobin at study end
Change in mean haemoglobin between the start and end of the intervention
Incidence of visits to health care facilities (drug shops, clinics, pharmacies, hospitals) and hospitalizations per participant
Mortality rate
Economic outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startJul 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, University of California, San Francisco
- Responsible party
- Principal investigator, Brian Greenwood, London School of Hygiene and Tropical Medicine
- Investigators
- Sarah G Staedke, MD, Principal investigator, University of California, San FranciscoChristopher JM Whitty, FRCP, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115921
- Sponsor's protocol ID
- ITCRVG40
- Status last verified
- Jan 2017
- First submitted
- 26 Jun 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Staedke SG, Mwebaza N, Kamya MR, Clark TD, Dorsey G, Rosenthal PJ, Whitty CJ. Home management of malaria with artemether-lumefantrine compared with standard care in urban Ugandan children: a randomised controlled trial. Lancet. 2009 May 9;373(9675):1623-31. doi: 10.1016/S0140-6736(09)60328-7. Epub 2009 Apr 9.
PubMed 19362361
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Home-Based Management of Fever in Urban Ugandan Children
- ClinicalTrials.gov ID
- NCT00115921
- Acronym / sponsor ID
- ITCRVG40
- Keywords
- Home-based care, Malaria, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Makerere University, University of California, San Francisco
- Study start
- Jul 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 27 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.
Detailed description
Population: Representative sample of Ugandan children aged 1 to 5 years from 400 households (approximately 540 children).
Clinical Site: The study will be conducted in the Mulago III parish community of Kampala, Uganda.
Study Duration: 13 months
Study Intervention: *Pilot period: After enrollment, households will participate in a one month pilot period to test the household pictorial diaries. At the end of the pilot period, households will be randomized to participation in the home-based management of fever (HBMF) arm or standard care arm for the remainder of the study (12 months). *HBMF arm: Households randomized to the HBMF group will be provided with pre-packaged coartemether to keep at home. Primary caregivers will be instructed to treat children participating in the study empirically with coartemether at home when the child develops fever. Study personnel will distribute drugs and educate the caregivers about administration of drugs, recognition of danger signs of fever/malaria, and when to seek additional care. *Standard care: Households randomized to the standard care arm will be asked to continue their current behaviour and to manage fever in their children as they would normally.
Measurements: Household diaries and monthly visits. Primary caregivers will be asked to keep a diary regarding the health of study participants for the duration of the study (13 months). Information on illnesses, treatments given, visits to health care facilities, and health care expenditures will be collected. Study personnel will visit the households monthly to collect completed diaries. At each visit, questionnaires will be administered to gather additional data on the health of the participants and treatment seeking behaviour.
Clinical and laboratory evaluations: Temperature, height, weight, mid-upper arm circumference, spleen size, haemoglobin, and thick blood smear will be assessed at enrollment, and at the beginning and end of the intervention period.
Study Objectives: 1. To measure the impact of home-based management of fever with coartemether on malaria-related morbidity compared to the current standard of care in the community.
- To measure the impact of home-based management of fever with coartemether on economic measures compared to the current standard of care in the community.
Primary outcome: Treatment incidence density (treatments per time at risk) for each treatment arm
Secondary clinical outcomes: 1) mean days of fever; 2) incidence of febrile episodes; 3) mean haemoglobin at study end; 4) change in mean haemoglobin; 5) prevalence of splenomegaly; 6) prevalence of parasitaemia; 7) incidence of visits to health care facilities, and hospitalizations; 8) mortality rate; 9) anthropometric measurements; 10) proportion of "appropriate" treatments; 11) proportion of delayed treatments; 12) treatment incidence density of treatments given at >50% and at full dose
Economic outcomes: 1) household cost/febrile episode; 2) household costs for treatment of febrile episode/month; 3) provider cost/child for delivery of HBMF; 4) estimated provider facility cost/patient for uncomplicated fever, and for severe disease; 5) total net cost/child/year; 6) net cost/additional child appropriately treated; 7) net cost/day of fever averted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1 - 5 years
- Agreement of parents or guardians to provide informed consent
- Live in Mulago III Parish
Key exclusion criteria (5 listed)
- History of any known serious chronic disease requiring frequent medical care (e.g. AIDS, sickle cell disease, malignancy)
- Intention to move from Kampala during the 13 month follow-up period
- History of serious side effects to study medications
- Weight < 10 kg
- Severe malnutrition defined as a weight-for-height or height-for-age Z-score < - 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of antimalarial treatment at home | Behavioural | – |
Primary outcome
The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.
7 secondary outcomes
Mean days of fever per participant
Incidence of febrile episodes
Mean haemoglobin at study end
Change in mean haemoglobin between the start and end of the intervention
Incidence of visits to health care facilities (drug shops, clinics, pharmacies, hospitals) and hospitalizations per participant
Mortality rate
Economic outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 19362361Staedke SG, Mwebaza N, Kamya MR, Clark TD, Dorsey G, Rosenthal PJ, Whitty CJ. Home management of malaria with artemether-lumefantrine compared with standard care in urban Ugandan children: a randomised controlled trial. Lancet. 2009 May 9;373(9675):1623-31. doi: 10.1016/S0140-6736(09)60328-7. Epub 2009 Apr 9.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah G Staedke, MD principal investigator
University of California, San Francisco
Christopher JM Whitty, FRCP principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Provision of antimalarial treatment at home in people with Malaria and Anemia, run by London School of Hygiene and Tropical Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.