A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum

Clinical Infectious Diseases

Volumn 36, Issue 5, 2003, Pages 541-549

  Hale, Braden R ^a   Owusu Agyei, Seth ^b   Fryauff, David J ^d   Koram, Kwadwo A ^c   Adjuik, Martin ^b   Oduro, Abraham R ^b   Prescott, W Roy ^e   Baird, J Kevin ^c   Nkrumah, Francis ^d   Ritchie, Thomas L ^d   Franke, Eileen D ^a   Binka, Fred N ^b,f   Horton, John ^g   Hoffman, Stephen L ^d,h  

^a US Navy Medical Research Unit No 3   (Egypt)

^b NAVRONGO HEALTH RESEARCH CENTRE   (Ghana)

^c University of Ghana   (Ghana)

^d NAVAL MEDICAL RESEARCH CENTER   (United States)

^e US Army Medical Materiel Development Activity   (United States)

^f WORLD HEALTH ORGANIZATION   (Switzerland)

^g GLAXOSMITHKLINE   (United Kingdom)

^h SANARIA INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MEFLOQUINE; TAFENOQUINE;

ABDOMINAL PAIN; ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BLOOD SMEAR; CHEMOPROPHYLAXIS; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DYSENTERY; FEMALE; GASTRITIS; GASTROINTESTINAL SYMPTOM; GHANA; HEADACHE; HUMAN; LABORATORY TEST; MAJOR CLINICAL STUDY; MALARIA; MALARIA CONTROL; MALE; MUSCULOSKELETAL DISEASE; MYALGIA; PLASMODIUM FALCIPARUM; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SIDE EFFECT; SORE THROAT; THROMBOCYTE AGGREGATION; THROMBOCYTOPENIA; TREATMENT OUTCOME;

ADULT; AGED; AMINOQUINOLINES; ANIMALS; ANTIMALARIALS; CHEMOPREVENTION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALARIA, FALCIPARUM; MALE; MIDDLE AGED; PLASMODIUM FALCIPARUM; TREATMENT OUTCOME;

EID: 0037373440     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/367542     Document Type: Article

References (29)

1. Fryauff, DJ, Baird, JK, Basri, H, Sumawinata, I, et al. Randomised placebo-controlled trial of primaquine phosphate for prophylaxis of falciparum and vivax malaria. Lancet 1995; 346:1190-3.
2. Weiss WR, Oloo AJ, Johnson A, Koech D, Hoffman SL. Daily primaquine for prophylaxis against falciparum malaria in Kenya: comparison with mefloquine, doxycycline, and chloroquine plus proguanil. J Infect Dis 1995; 171:1569-75.
3. Soto J, Toledo J, Rodriguez M, et al. Primaquine prophylaxis against malaria in non-immune Colombian soldiers: efficacy and toxicity: a randomized, double-blind, placebo-controlled trial. Ann Intern Med 1998; 129:241-4.
4. Baird JK, Lacy MD, Barcus MJ, et al. Randomized, parallel placebo-controlled trial of primaquine for malaria prophylaxis in Papua, Indonesia. Clin Infect Dis 2001; 33:1990-7.
5. Fryauff DJ, Baird JK, Purnomo, et al. Malaria in a nonimmune population after extended chloroquine or primaquine prophylaxis. Am J Trop Med Hyg 1997; 56:137-40.
6. Shanks GD, Kremsner PG, Sukwa TY, et al. Atovaquone and proguanil hydrochloride for prophylaxis of malaria. J Travel Med 1999; 6(Suppl 1):S21-7.
7. Berman JD, Nielsen R, Chulay JD, et al. Causal prophylactic efficacy of atovaquone-proguanil (Malarone) in a human challenge model. Trans R Soc Trop Med Hyg 2001; 95:429-32.
8. Ling JD, Baird JK, Fryauff DJ, et al. Randomized, placebo-controlled trial of atovaquone/proguanil for the prevention of Plasmodium falciparum or Plasmodium vivax malaria among migrants to Papua, Indonesia. Clin Infect Dis 2002; 35:825-33.
9. Looareesuwan S, Willairatana P, Glanarongran R, et al. Atovaquone and proguanil hydrochloride followed by primaquine for treatment of Plasmodium vivax malaria in Thailand. Trans R Soc Trop Med Hyg 1999; 93:637-40.
10. Kyle D, Webster K. Gametocytocidal and sporontocidal activity against Plasmodium falciparum. Am J Trop Med Hyg 1997; 57(Suppl):3-83.
11. Brueckner, RP, Coster, T, Wesche, DL, et al. Prophylaxis of Plasmodium falciparum infection in a human challenge model with WR 238605, a new 8-aminoquinoline antimalarial. Antimicrob Agents Chemother 1998; 42:1293-4.
12. Cooper RD, Milhous WK, Reickmann KH. The efficacy of WR238605 against the blood stages of a chloroquine resistant strain of Plasmodium vivax. Trans R Soc Trop Med Hyg 1994; 88:691-2.
13. Peters W. The evolution of tafenoquine - antimalarial for a new millennium? J R Soc Med 1999; 92:345-52.
14. Brueckner RP, Lasseter KC, Lin ET, Schuster BG. First-time-in-humans safety and pharmacokinetics of WR 238605, a new antimalarial. Am J Trop Med Hyg 1998; 58:645-9.
15. Arnold J, Alving AS, Hockwald RS, et al. The effects of continuous and intermittent primaquine therapy on the relapse rate of Chesson strain vivax malaria. J Lab Clin Med 1955; 44:429-37.
16. Beerahee M. Clinical pharmacology, of atovaquone and proguanil hydrochloride. J Travel Med 1999; 6(Suppl 1):S13-7.
17. Grewal RS. Pharmacology of 8-aminoquinolines. Bull World Health Organ 1981; 59:397-406.
18. Shanks GD, Kain KC, Keystone JS. Malaria chemoprophylaxis in the age of drug resistance. II. Drugs that may be available in the future. Clin Infect Dis 2001; 33:381-5.
19. Phillips-Howard PA, Wood D. The safety of antimalarial drugs in pregnancy. Drug Saf 1996; 14:131-45.
20. Lell B, Faucher JF, Missinou MA, et al. Malaria chemoprophylaxis with tafenoquine: a randomized study. Lancet 2000; 355:2041-5.
21. Shanks GD, Oloo AJ, Aleman GM, et al. A new primaquine analogue, tafenoquine (WR 238605), for prophylaxis against Plasmodium falciparum malaria. Clin Infect Dis 2001; 33:1975-80.
22. Owusu-Agyei S, Koram KA, Baird JK, et al. Incidence of symptomatic and asymptomatic Plasmodium falciparum infection following curative therapy in adult residents of northern Ghana. Am J Trop Med Hyg 2001; 65:197-203.
23. Koopman PAR. Confidence intervals for the ratio of two binomial proportions. Biometrics 1984; 40:513-7.
24. Lee ET. Statistical methods for survival data analysis. 2rid ed. New York: John Wiley & Sons, 1992:109-12.
25. Kelton JG, Keystone J, Moore J, et al. Immune-mediated thrombocytopenia of malaria. J Clin Invest 1983; 71:832-6.
26. Hviid L, Kurtzhalls JA, Goka BQ, et al. Rapid reemergence of T cells into peripheral circulation following treatment of severe and uncomplicated Plasmodium falciparum infection. Infect Immun 1997; 65:4090-3.
27. Kurtzhals JAL, Addae MM, Akanmori BD, et al. Anemia caused by asymptomatic Plasmodium falciparum infection in semi-immune African schoolchildren. Trans R Soc Trop Med Hyg 1999; 93:623-7.
28. Peters W. The chemotherapy-immunity interface. In: Chemotherapy and drug resistance in malaria. Vol 2. New York: Academic Press, 1987.
29. Walsh DS, Looareesuwan S, Wilairatana P, et al. Randomized dose-ranging study of the safety and efficacy of WR 238605 (Tafenoquine) in the prevention of relapse of Plasmodium vivax malaria in Thailand. J Infect Dis 1999; 180:1282-7.