Malaria Treatment With Injectable ArteSunate
Information source: Swiss Tropical & Public Health Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Malaria
Intervention: No intervention (Other)
Phase: N/A
Status: Completed
Sponsored by: Swiss Tropical & Public Health Institute Official(s) and/or principal investigator(s): Christian Burri, PhD, Principal Investigator, Affiliation: Swiss Tropical & Public Health Institute Antoinette Tshefu, MD, Principal Investigator, Affiliation: Kinshasa School of Public Health
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.
Clinical Details
Official title: Treatment of Severe Malaria - An Operational Comparative Study Between Quinine and Artesunate for the Treatment of Severe Malaria in Hospitals and Health Centers of Kinshasa and Lower Congo
Study design: Time Perspective: Prospective
Primary outcome: Duration of hospitalization (from registration to discharge)
Detailed description:
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.
Eligibility
Minimum age: 2 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Centre Hospitalier Roi Baudoin 1er Masina, Kinshasa, Congo, The Democratic Republic of the
Centre de Santé CECO, Kimpese, Bas Congo, Congo, The Democratic Republic of the
Centre de Santé la Famille, Kimpese, Bas Congo, Congo, The Democratic Republic of the
Hôpital Général de Référence IME, Kimpese, Bas Congo, Congo, The Democratic Republic of the
Centre de Santé Ngeba, Kisantu, Bas Congo, Congo, The Democratic Republic of the
Hôpital Saint Luc de Kisantu, Kisantu, Bas Congo, Congo, The Democratic Republic of the
Centre de Santé Bita, Maluku, Kinshasa, Congo, The Democratic Republic of the
Centre de Santé Menkao, Maluku, Kinshasa, Congo, The Democratic Republic of the
Centre Hospitalier d'État de Maluku, Maluku, Kinshasa, Congo, The Democratic Republic of the
Additional Information
Related publications: 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. Erratum in: Lancet. 2011 Jan 8;377(9760):126. 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. 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. 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.
Starting date: April 2013
Last updated: September 12, 2013
|