Meta AnalysisID 4042

奎宁治疗无并发症耐药疟疾

CRD42013005283

To evaluate the efficacy and safety of quinine (alone or in combination with other anti-malarials) for treating uncomplicated drug-resistant malaria.

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Meta Analysis Id: 4042
Evidence Id: 12600
Core Evidence Id: 12600
Source Meta Analysis Id: 4002
Herb2 Meta Analysis Id: HBMA004002
Crd Id: CRD42013005283
Title: Quinine for treating uncomplicated resistant malaria
Review Question: To evaluate the efficacy and safety of quinine (alone or in combination with other anti-malarials) for treating uncomplicated drug-resistant malaria.
Study Type Included: Randomised controlled trials.
Condition Being Studied: Malaria - Malaria remains the most important disease of public health significance for the vast majority of people living in sub Saharan Africa many countries in Asia and the Americas. It is transmitted in 108 countries where about three billion people live. It is caused by the protozoa Plasmodium (Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium knowlesi and Plasmodium malariae) following the bite of an infected female Anopheles mosquito. P. falciparum predominates in Africa, New Guinea, and Hispaniola while P. vivax is more common in Central America. Infection with Plasmodium falciparum can lead to severe malaria, particularly in children under 5 years of age, pregnant women and in non-immune adults. Control programmes for malaria in countries where malaria is endemic face huge problems as a result of the weak health and social systems in many of these countries. This results in a high incidence of drug resistant parasites. Antimalaria drug resistance is the ability of a parasite strain to multiply or to survive in the presence of concentrations of a drug that would normally destroy parasites of the same species or prevent their multiplication. Drug resistance is one of the major causes of the deterioration in the malaria control situation in many endemic countries.
Participant: Children and adults with resistant malaria (defined as parasitologically confirmed treatment failure following a complete treatment course with an anti-malarial drug other than quinine).
Animal
Human Disease Modelled
Intervention: Quinine given alone (monotherapy) or in combination with other anti-malarials.
Comparator Control: Control arm would consist of any other effective anti-malarial drug.
Main Outcome: 1) Early treatment failure (including RIII parasitological failure). For purposes of the review we would define Early Treatment Failure as development of danger signs or severe malaria on Day 1, 2 or 3, in the presence of parasitaemia; parasitaemia on Day 2 higher than on Day 0, irrespective of axillary temperature; parasitaemia on Day 3 with axillary temperature >37.5°C; and parasitaemia on Day 3, >25% of count on Day 0. We would define RIII Parasitemia as minimal reduction in asexual parasitemia, (decrease <25%) or an increase in parasitemia after 48 hours. 2) Parasitological cure by day 28.
Outcome Measure
Additional Outcome: Secondary outcomes 1. Clinical cure (including all the patients who meet criteria for Adequate Clinical and Parasitological Response - ACPR) 2.Late clinical failure defined as development of danger signs or severe malaria in the presence of parasitaemia on any day between Day 4 and Day 28 (or Day 42) in patients who did not previously meet any of the criteria of early treatment failure; and presence of parasitaemia on any day between Day 4 and Day 28 (Day 42) with axillary temperature >37.5°C in patients who did not previously meet any of the criteria of early treatment failure. 3. Late parasitological failure (including failures reported as RI and RII) - Late Parasitological failure is defined as presence of parasitaemiaon any day between Day 7 and Day 28 with axillary temperature <37.5°C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure RI, Delayed Recrudescence: defined as reduction of asexual parasitemia to < 25% of pre-treatment level in 48 hours, but reappears between 2-4 weeks. RI, Early Recrudescence: The asexual parasitemia reduces to < 25% of pre-treatment level in 48 hours, but reappears before 2 weeks. RII Resistance: defined as marked reduction in asexual parasitemia (decrease >25% but <75%) in 48 hours, without complete clearance in 7 days. 4. Parasite clearance time - defined as the time from the start of treatment until the first time the blood smear became negative for asexual parasites and remained negative at two consecutive measurements. 5. Fever clearance time - defined as the time from baseline until the start of the period in which the measured temperature remained below 37.5°C for at least 24 hours 6. Adherence - defined as number of participants that follow trialist treatment instructions and complete prescribed therapy per arm. 7. Adverse events (sub-categorized as non-serious and serious adverse events) 8. Data on hospitalization, progression to severe malaria and fatalities will all be documented as serious adverse events.
Study Method: Intervention
Keyword: Humans; Quinine; Malaria
Contact: Chibuzo Odigwe [email protected]
Organisational Affiliation: Institute of Tropical Disease Research and Prevention,University of Calabar Teaching Hospital, Calabar
Funding Source: Effective Health Care Research Programme, Institute of Tropical Disease Research and Prevention, University of Calabar Teaching Hospital, Calabar
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language: English
Country: Nigeria
Review Stage: Review Ongoing
First Submission Date
Registration Date: 2013-08-05
Anticipated Start Date: 2013-08-01
Anticipated Completion Date: 2013-09-27
Title Cn: 奎宁治疗无并发症耐药疟疾
Title En: Quinine for treating uncomplicated resistant malaria
Bilingual Status: complete