Malaria Treatment With Injectable ArteSunate

NCT01828333 | Completed

• 1 other identifier: Swiss TPH P 001-01-12
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 9

Brief Summary

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

Severe Malaria

Keywords

Malaria; Severe; Artesunate; Quinine; Democratic Republic of Congo

Outcome Measures

Primary Outcomes (1)

• Duration of hospitalization (from registration to discharge)

  3-7 days

Other Outcomes (5)

• Clinical assessment

  28 days

• Laboratory assessment (exploratory - (see explanation in 1.1.4)

  28 days

• Time and motion study

  28 days

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Intravenous artesunate - new routine in DRC

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Medicines for Malaria Venture: collaborator

Study Sites (9)

Centre de Santé CECO

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

Location

Centre de Santé la Famille

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

Location

Hôpital Général de Référence IME

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

Location

Centre de Santé Ngeba

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

Location

Hôpital Saint Luc de Kisantu

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

Location

Centre Hospitalier Roi Baudoin 1er Masina

Kinshasa, Kinshasa City, Democratic Republic of the Congo

Location

Centre de Santé Bita

Maluku, Kinshasa City, Democratic Republic of the Congo

Location

Centre de Santé Menkao

Maluku, Kinshasa City, Democratic Republic of the Congo

Location

Centre Hospitalier d'État de Maluku

Maluku, Kinshasa City, Democratic Republic of the Congo

Location

Related Publications (5)

• 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.

  PMID: 21062666 BACKGROUND

• 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.

  PMID: 16125588 BACKGROUND

• 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.

  PMID: 21734764 BACKGROUND

• 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.

  PMID: 23302816 BACKGROUND

• 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.

  PMID: 26024661 DERIVED

MeSH Terms

Conditions

Malaria; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Christian Burri, PhD

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

• Antoinette Tshefu, MD

  Kinshasa School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: April 10, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

DE (9)