Efficacy and safety of artemether-lumefantrine (Coartem®) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria

Transactions of the Royal Society of Tropical Medicine and Hygiene

Volumn 99, Issue 6, 2005, Pages 459-467

  Falade, Catherine ^a   Makanga, Michael ^b   Premji, Zul ^c   Ortmann, Christine Elke ^d   Stockmeyer, Marlies ^d   Ibarra de Palacios, Patricia ^d  

^a UNIVERSITY OF IBADAN   (Nigeria)

^b KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^c MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES   (Tanzania)

^d NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Africa; Antimalarials; Co artemether; Malaria; Plasmodim falciparum

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; HEMOGLOBIN;

ACUTE DISEASE; ANEMIA; ANOREXIA; ARTICLE; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE EXACERBATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; EOSINOPHILIA; FEMALE; FEVER; FOLLOW UP; GASTROENTERITIS; GASTROINTESTINAL DISEASE; HEMATOLOGIC DISEASE; HEPATOMEGALY; HUMAN; IMMUNITY; INFANT; KENYA; MAJOR CLINICAL STUDY; MALARIA CONTROL; MALARIA FALCIPARUM; MALE; MULTICENTER STUDY; MULTIDRUG RESISTANCE; NIGERIA; OPEN STUDY; PARASITEMIA; PLASMODIUM FALCIPARUM; POLYMERASE CHAIN REACTION; PRESCHOOL CHILD; QT PROLONGATION; REGRESSION ANALYSIS; SIDE EFFECT; SPLENOMEGALY; TABLET; TANZANIA; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; VIRUS HEPATITIS; VOMITING;

ACUTE DISEASE; ANTIMALARIALS; ARTEMISININS; CHILD; CHILD, PRESCHOOL; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; FLUORENES; HEART RATE; HEMATOLOGIC TESTS; HUMANS; INFANT; KENYA; MALARIA, FALCIPARUM; MALE; NIGERIA; PARASITE EGG COUNT; SESQUITERPENES; SEX DISTRIBUTION; TANZANIA; TIME FACTORS; TREATMENT OUTCOME;

PLASMODIUM FALCIPARUM;

EID: 17144379315     PISSN: 00359203     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.trstmh.2004.09.013     Document Type: Article

References (23)

1. R. Bakshi I. Hermeling-Fritz I. Gathmann E. Alteri An integrated assessment of the clinical safety of artemether-lumefantrine: A new oral fixed-dose combination antimalarial drug Trans. R. Soc. Trop. Med. Hyg. 94 2000 419-424
2. M. Bindschedler G. Lefèvre F. Ezzet N. Schaeffer I. Meyer M.S. Thomsen Cardiac effects of co-artemether (artemether/lumefantrine) and mefloquine given alone or in combination to healthy volunteers Eur. J. Clin. Pharmacol. 56 2000 375-381
3. D. Bunnag C. Viravan S. Looareesuwan J. Karbwang T. Harinasuta Clinical trial of artesunate and artemether on multidrug resistant falciparum malaria in Thailand. A preliminary report Southeast Asian J. Trop. Med. Public Health 22 1991 380-385
4. Committee for Proprietary Medicinal Products, 1997. Points to consider: the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products. London, EMEA, CPMP/986/86.
5. F. Ezzet R. Mull J. Karbwang Population pharmacokinetics and therapeutic response of CGP 56697 (artemether + benflumetol) in malaria patients Br. J. Clin. Pharmacol. 46 1998 553-561
6. P.R. Fischer R. Bialek Prevention of malaria in children Clin. Infect. Dis. 34 2002 493-498
7. C. Hatz S. Abdulla R. Mull D. Schellenberg I. Gathmann P. Kibatala H.P. Beck M. Tanner C. Royce Efficacy and safety of CGP 56697 (artemether and benflumetol) compared with chloroquine to treat acute falciparum malaria in Tanzanian children aged 1-5 years Trop. Med. Int. Health 3 1998 498-504
8. L. Henning I. Felger H.-P. Beck Rapid DNA extraction for molecular epidemiological studies of malaria Acta. Trop. 72 1999 149-155
9. A. Irion S. Abdullaii I. Felger H.P. Beck R. Mull C. Hatz A comparative trial of CGP 56697 and chloroquine in Tanzanian children with subsequent PCR analysis of reoccuring parasites In: Fifth International Conference on Travel Medicine 1997 (abstract)
10. N.A. Kshirsagar N.J. Gogtay N.S. Moorthy M.R. Garg S.S. Dalvi A.R. Chogle J.S. Sorabjee S.N. Marathe G.H. Tilve A.D. Bhatt S.P. Sane R. Mull I. Gathmann A randomized, double-blind, parallel-group, comparative safety, and efficacy trial of oral co-artemether versus oral chloroquine in the treatment of acute, uncomplicated Plasmodium falciparum malaria in adults in India Am. J. Trop. Med. Hyg. 62 2000 402-408
11. G. Lefèvre M.S. Thomsen Clinical pharmacokinetics of artemether and lumefantrine (Riamet®) Clin. Drug Invest. 18 1999 467-480
12. G. Lefèvre S. Looareesuwan S. Treeprasertsuk S. Krudsood U. Silachamroon I. Gathmann R. Mull R. Bakshi A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand Am. J. Trop. Med. Hyg. 64 2001 247-256
13. E.S. Lugada J. Mermin F. Kaharuza E. Ulvestad W. Were N. Langeland B. Asjo B. Malamba R. Downing Population-based hematologic and immunologic reference values for a healthy Ugandan population Clin. Diagn. Lab. Immunol. 11 2004 29-34
14. A.M. Nyakeriga M. Troye-Blomberg J.R. Dorfman N.D. Alexander R. Back M. Kortok A.K. Chemtai K. Marsh T.N. Williams Iron deficiency and malaria among children living on the coast of Kenya J. Infect. Dis. 190 2004 439-447
15. R. Price M. van Vugt L. Phaipun C. Luxemburger J. Simpson R. McGready F. ter Kuile A. Kham T. Chongsuphajaisiddhi N.J. White F. Nosten Adverse effects in patients with acute falciparum malaria treated with artemisinin derivatives Am. J. Trop. Med. Hyg. 60 1999 547-555
16. L.A.S. Salako F.O. Ajayi A. Sowunmi O. Walker Malaria in Nigeria: A revisit Ann. Trop. Med. Parasitol. 84 1990 435-445
17. G. Snounou H.-P. Beck The use of PCR genotyping in the assessment of recrudescence or reinfection after antimalarial drug treatment Parasitol. Today 14 1998 462-467
18. M.V. Van Vugt P. Wilairatana B. Gemperli I. Gathmann L. Phaipun A. Brockman C. Luxemburger N.J. White F. Nosten S. Loowareesuwan Efficacy of six doses of artemether-lumefantrine (benflumetol) in multidrug-resistant Plasmodium falciparum malaria Am. J. Trop. Med. Hyg. 60 1999 936-942
19. M. Van Vugt S. Looareesuwan P. Wilairatana R. McGready L. Villegas I. Gathmann R. Mull A. Brockman N.J. White F. Nosten Artemether-lumefantrine for the treatment of multidrug-resistant falciparum malaria Trans. R. Soc. Trop. Med. Hyg. 94 2000 545-548
20. L. Von Seidlein S. Jaffar M. Pinder M. Haywood G. Snounou B. Gemperli I. Gathmann C. Royce B. Greenwood Treatment of African children with uncomplicated falciparum malaria with a new antimalarial drug, CGP 56697 J. Infect. Dis. 176 1997 1113-1116
21. L. Von Seidlein K. Bojang P. Jones S. Jaffar M. Pinder S. Obaro T. Doherty M. Haywood G. Snounou B. Gemperli I. Gathmann C. Royce K. McAdam B. Greenwood A randomized controlled trial of artemether/benflumetol, a new antimalarial and pyrimethamine/sulfadoxine in the treatment of uncomplicated falciparum malaria in African children Am. J. Trop. Med. Hyg. 58 1998 638-644
22. N.J. White P.L. Olliaro Strategies for the prevention of antimalarial drug resistance: Rationale for combination chemotherapy for malaria Parasitol. Today 12 1996 399-401
23. WHO, 2000. The use of Antimalarial Drugs: Report on an Informal Consultation, 13-17 November 2000. World Health Organization, Geneva, WHO/CDS/RBM/2001.33.