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Malaria Treatment With Injectable ArteSunate

NCT ID: NCT01828333

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Severe Malaria

Keywords

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Malaria Severe Artesunate Quinine Democratic Republic of Congo

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Intravenous artesunate - new routine in DRC

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.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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):

* impaired consciousness or unrousable coma
* prostration, i.e. generalized weakness so that the patient is unable walk or sit up without assistance
* failure to feed
* multiple convulsions - more than two episodes in 24 h
* deep breathing, respiratory distress (acidotic breathing)
* circulatory collapse or shock, systolic blood pressure \< 70 mm Hg in adults and \< 50 mm Hg in children
* clinical jaundice plus evidence of other vital organ dysfunction

Complementary Laboratory findings (hospitals only)

* severe anaemia (Hb \< 5g/dl, packed cell volume \< 15%)
* hypoglycemia (blood glucose \< 2.2 mmol/l or \< 40 mg/dl)
* metabolic acidosis (plasma bicarbonate \< 15 mmol/l)
* serum creatinine \> 265 ìmol/l suggesting renal impairment

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.
Minimum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicines for Malaria Venture

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Burri, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Tropical & Public Health Institute

Antoinette Tshefu, MD

Role: PRINCIPAL_INVESTIGATOR

Kinshasa School of Public Health

Locations

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Centre de Santé CECO

Kimpese, Bas-Congo Province, Democratic Republic of the Congo

Site Status

Centre de Santé la Famille

Kimpese, Bas-Congo Province, Democratic Republic of the Congo

Site Status

Hôpital Général de Référence IME

Kimpese, Bas-Congo Province, Democratic Republic of the Congo

Site Status

Centre de Santé Ngeba

Kisantu, Bas-Congo Province, Democratic Republic of the Congo

Site Status

Hôpital Saint Luc de Kisantu

Kisantu, Bas-Congo Province, Democratic Republic of the Congo

Site Status

Centre Hospitalier Roi Baudoin 1er Masina

Kinshasa, Kinshasa City, Democratic Republic of the Congo

Site Status

Centre de Santé Bita

Maluku, Kinshasa City, Democratic Republic of the Congo

Site Status

Centre de Santé Menkao

Maluku, Kinshasa City, Democratic Republic of the Congo

Site Status

Centre Hospitalier d'État de Maluku

Maluku, Kinshasa City, Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

References

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Dondorp AM, Fanello CI, Hendriksen IC, Gomes E, Seni A, Chhaganlal KD, Bojang K, Olaosebikan R, Anunobi N, Maitland K, Kivaya E, Agbenyega T, Nguah SB, Evans J, Gesase S, Kahabuka C, Mtove G, Nadjm B, Deen J, Mwanga-Amumpaire J, Nansumba M, Karema C, Umulisa N, Uwimana A, Mokuolu OA, Adedoyin OT, Johnson WB, Tshefu AK, Onyamboko MA, Sakulthaew T, Ngum WP, Silamut K, Stepniewska K, Woodrow CJ, Bethell D, Wills B, Oneko M, Peto TE, von Seidlein L, Day NP, White NJ; AQUAMAT group. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet. 2010 Nov 13;376(9753):1647-57. doi: 10.1016/S0140-6736(10)61924-1. Epub 2010 Nov 7.

Reference Type BACKGROUND
PMID: 21062666 (View on PubMed)

Dondorp A, Nosten F, Stepniewska K, Day N, White N; South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet. 2005 Aug 27-Sep 2;366(9487):717-25. doi: 10.1016/S0140-6736(05)67176-0.

Reference Type BACKGROUND
PMID: 16125588 (View on PubMed)

Lubell Y, Riewpaiboon A, Dondorp AM, von Seidlein L, Mokuolu OA, Nansumba M, Gesase S, Kent A, Mtove G, Olaosebikan R, Ngum WP, Fanello CI, Hendriksen I, Day NP, White NJ, Yeung S. Cost-effectiveness of parenteral artesunate for treating children with severe malaria in sub-Saharan Africa. Bull World Health Organ. 2011 Jul 1;89(7):504-12. doi: 10.2471/BLT.11.085878. Epub 2011 Apr 28.

Reference Type BACKGROUND
PMID: 21734764 (View on PubMed)

Centers for Disease Control and Prevention (CDC). Published reports of delayed hemolytic anemia after treatment with artesunate for severe malaria--worldwide, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Jan 11;62(1):5-8.

Reference Type BACKGROUND
PMID: 23302816 (View on PubMed)

Ferrari G, Ntuku HM, Burri C, Tshefu AK, Duparc S, Hugo P, Mitembo DK, Ross A, Ngwala PL, Luwawu JN, Musafiri PN, Ngoie SE, Lengeler C. An operational comparative study of quinine and artesunate for the treatment of severe malaria in hospitals and health centres in the Democratic Republic of Congo: the MATIAS study. Malar J. 2015 May 30;14:226. doi: 10.1186/s12936-015-0732-1.

Reference Type DERIVED
PMID: 26024661 (View on PubMed)

Other Identifiers

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Swiss TPH P 001-01-12

Identifier Type: -

Identifier Source: org_study_id