An observational study in Severe Malaria, sponsored by Swiss Tropical & Public Health Institute. Completed at 9 sites in Democratic Republic of the Congo. Open to participants aged 2 Months and older. Per ClinicalTrials.gov, last updated 2013-09-13.
Sponsored by Swiss Tropical & Public Health Institute · Observational
The MATIAS study aims to demonstrate through limited scope implementation studies how injectable artesunate may be progressively rolled out nationwide in the Democratic Republic of the Congo as the preferred treatment for severe malaria.
In 2010 the AQUAMAT study demonstrated that the treatment of severe malaria with artesunate in children reduced the case fatality substantially. An overall reduction of 22.5 % of mortality in African children (\< 15 years) was reported using injectable artesunate compared to injectable quinine for treatment of severe malaria caused by Plasmodium falciparum. These results with high quality evidence led to a change in the WHO guidelines for the treatment of severe malaria in 2011. The WHO now recommends intravenous artesunate as the treatment of choice for severe malaria in children and adults. In early 2012 the Programme National de Lutte contre of Paludisme (PNLP) of the DRC with support from the relevant ministry departments decided to follow the WHO guidelines and changed the policy for the treatment of severe malaria in children and adults from injectable quinine to injectable artesunate. However, this process is a complex undertaking, requiring many operational and clinical adaptations. In order to support this process, there is a need for on-site operational information on the process and consequences of the switch from quinine to artesunate. The MATIAS study aims to demonstrate through limited scope implementation studies how injectable artesunate may be progressively rolled out nationwide in the Democratic Republic of the Congo as the preferred treatment for severe malaria.
1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 350 is below the median of 600 across 220 observational studies indexed under Malaria.
Browse Malaria studies →Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with severe malaria will be enrolled in four hospitals and five health centers located in four health zones of the Democratic Republic of the Congo, three rural and one urban.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients (= 2 months old) admitted to one of the study sites and treated for severe malaria with IV quinine in the first part of the study and patients treated with IV/IM artesunate in the second part of the study will be included. Patients need to fulfill the WHO criteria for severe malaria and must be unable to take oral treatment (WHO, 2010, WHO, 2011). In addition all participants need to give their informed consent
Conditions: Positive rapid diagnostic test (RDT) for Plasmodium falciparum HRP2 or lactate dehydrogenase and/or a positive blood slide (thick smear). Patient will be considered to be positive if one of the two tests is positive. In case of negative result of both tests, the patient will not be enrolled in the study and will receive care according to the usual routine practice in the hospital/health center in question.
Definition of severe malaria according to WHO (WHO, 2010): In a patient with P. falciparum asexual parasitaemia and no other obvious cause for the symptoms, the presence of one or more of the following clinical or laboratory features classifies the patient as suffering from severe malaria:
Clinical features (hospitals and health centers):
Complementary Laboratory findings (hospitals only)
Exclusion Criteria:
Patients with known serious adverse reactions to quinine and artemisinin derivatives or patients who have received adequate antimalarial treatment 24 hours before admission will not be included in the study.
Women with known or suspected pregnancy in all trimesters will not be included in the study and will be treated with quinine infusions according to the new national DRC guidelines (Programme Nationale de Lutte contre le Paludisme, 2012). According to current routine procedures determination of pregnancy will be done by medical anamnesis and/ or by a positive pregnancy test.
350 patients to be enrolled A first study group with the currently used standard for treatment of severe malaria in the DRC, i.v. quinine, was enrolled from 21 October 2012 to 15 January 2013. This study was initially planned as limited scope implementation study with pure observational character (routine diagnosis and treatment, time and motion study, feasibility assessment and costing) and thus not registered. Due to additional publications on i.v. artesunate, non-routine testing for hemoglobin levels before and after treatment plus non-routine follow up was added: Registration of study at this point.
Other: No intervention
No intervention
Duration of hospitalization (from registration to discharge)
Time frame: 3-7 days
Clinical assessment
* Time from start of IV/IM treatment to initiation of oral treatment * Parasite clearance time * Clinical status at discharge * Signs for tiredness and breathlessness at follow up
Time frame: 28 days
Laboratory assessment (exploratory - (see explanation in 1.1.4)
\- Hemoglobin nadir during follow up period of 28 days
Time frame: 28 days
Time and motion study
\- Cumulative staff time required for all steps of patient management, including drug administration
Time frame: 28 days
Feasibility and acceptability study
* Perceived feasibility of patient management (as assessed and graded by provider questionnaire) * Perceived ease of application of drug treatment (as assessed and graded by provider questionnaire) * Perceived quality of case management (including perceived adverse effects) by patient / caretaker (as assessed through patient / caretaker questionnaire)
Time frame: 28 days
Analysis of financial cost
\- Total financial cost of patient management including treatment
Time frame: 28 days
The record gives a start of Apr 2013, a primary completion of Jun 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Swiss Tropical & Public Health Institute