MalariaPhase 4NCT00687895
Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania
A Phase 4 study testing Clinical algorithm and microscopy diagnosis of malaria in people with Malaria, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.
Trial summary
General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Clinical algorithm and microscopy diagnosis of malaria
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,131 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2003to Mar 2004
- Phase
- Phase 4
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- below five years of age
- fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
- able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
- the mother/guardian or caretaker consented to participate
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
dispensaries/health centers in Kibaha and Bagamoyo
Coast, Pwani Region
About this study
Official title: Quality Malaria Case Management In Under- Fives In Primary Health Care (Phc) Institutions In Bagamoyo And Kibaha Districts Of Coastal Tanzania:a Multicomponent Controlled Intervention Study
General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs
Read the detailed description
PHC facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from Muhimbili University College of Health Sciences (MUCHS), Dar es Salaam
All children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:
- below five years of age
- fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
- able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
- the mother/guardian or caretaker consented to participate.
Patients with severe disease and/or general danger signs requiring inpatient care according to the IMCI guidelines were admitted or referred to the health centers or the district hospitals
- Conditions
- Malaria
- Being tested
- Clinical algorithm and microscopy diagnosis of malaria
- Keywords
- malaria microscopy primary health care children
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical algorithm and microscopy diagnosis of malariaProcedure or surgery
Clinical alogarithm
The content of the package included
- description of signs and symptoms of malaria disease
- history taking relevant to malaria and physical examination
- identification of danger signs and severe illness for referral
- appropriate treatment
- counseling patients on the use of drugs.
Malaria microscopy. contents
- make thick blood smears from patients with fever and stain with Giemsa
- identify and count malaria parasites
- maintain the microscope and store blood slides.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | training in clinical algorithm plus microscopy Receives: Procedure: Clinical algorithm and microscopy diagnosis of malaria |
| 2 | Experimental | clinical algorithm Receives: Procedure: Clinical algorithm and microscopy diagnosis of malaria |
| 3 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms
Measured: Day 0
Secondary outcomes (2)
prescriptions of antibiotics, cost of drugs
Measured: Day 0
health outcome of the patients
Measured: Day 1-6, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJul 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Investigators
- Anders Bjorkman, MD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687895
- Sponsor's protocol ID
- HF2003
- Status last verified
- May 2008
- First submitted
- 28 May 2008
- Last updated
- 2 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bates I, Bekoe V, Asamoa-Adu A. Improving the accuracy of malaria-related laboratory tests in Ghana. Malar J. 2004 Nov 1;3:38. doi: 10.1186/1475-2875-3-38.
PubMed 15516269Ngasala B, Mubi M, Warsame M, Petzold MG, Massele AY, Gustafsson LL, Tomson G, Premji Z, Bjorkman A. Impact of training in clinical and microscopy diagnosis of childhood malaria on antimalarial drug prescription and health outcome at primary health care level in Tanzania: a randomized controlled trial. Malar J. 2008 Oct 2;7:199. doi: 10.1186/1475-2875-7-199.
PubMed 18831737
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Malaria Case Management In Under- Fives In Primary Health Care (Phc) Institutions In Bagamoyo And Kibaha Districts Of Coastal Tanzania:a Multicomponent Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT00687895
- Acronym / sponsor ID
- HF2003
- Conditions
- Malaria
- Keywords
- malaria microscopy primary health care children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,131 participants (actual)
- Lead sponsor
- Muhimbili University of Health and Allied SciencesUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jul 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 2 Jun 2008 (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.
General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs
Detailed description
PHC facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from Muhimbili University College of Health Sciences (MUCHS), Dar es Salaam
All children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:
- below five years of age
- fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
- able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
- the mother/guardian or caretaker consented to participate.
Patients with severe disease and/or general danger signs requiring inpatient care according to the IMCI guidelines were admitted or referred to the health centers or the district hospitals
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Clinical algorithm and microscopy diagnosis of malariatraining in clinical algorithm plus microscopy |
| 2 | Experimental | Procedure: Clinical algorithm and microscopy diagnosis of malariaclinical algorithm |
| 3 | No intervention | –Control |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- below five years of age
- fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
- able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
- the mother/guardian or caretaker consented to participate
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Clinical algorithm and microscopy diagnosis of malariaClinical alogarithm The content of the package included 1. description of signs and symptoms of malaria disease 2. history taking relevant to malaria and physical examination 3. identification of danger signs and severe illness for referral 4. appropriate treatment 5. counseling patients on the use of drugs. Malaria microscopy. contents 1. make thick blood smears from patients with fever and stain with Giemsa 2. identify and count malaria parasites 3. maintain the microscope and store blood slides. | Procedure or surgery | 1, 2 |
Primary outcome
the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms
Time frame: Day 0
2 secondary outcomes
prescriptions of antibiotics, cost of drugs
Time frame: Day 0
health outcome of the patients
Time frame: Day 1-6, day 7
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 2 Jun 2008.
- Background: PubMed 15516269Bates I, Bekoe V, Asamoa-Adu A. Improving the accuracy of malaria-related laboratory tests in Ghana. Malar J. 2004 Nov 1;3:38. doi: 10.1186/1475-2875-3-38.
- Derived from this study: PubMed 18831737Ngasala B, Mubi M, Warsame M, Petzold MG, Massele AY, Gustafsson LL, Tomson G, Premji Z, Bjorkman A. Impact of training in clinical and microscopy diagnosis of childhood malaria on antimalarial drug prescription and health outcome at primary health care level in Tanzania: a randomized controlled trial. Malar J. 2008 Oct 2;7:199. doi: 10.1186/1475-2875-7-199.
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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.
Anders Bjorkman, MD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinical algorithm and microscopy diagnosis of malaria in people with Malaria, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.
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 4 inclusion and 1 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 2 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 proportion of study children receiving prescriptions of antimalarial drugs in the respective arms (time frame: Day 0). 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 NCT00687895, which also lists 2 linked publications.
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 2 Jun 2008.