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-
1
World Health Organization, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria. http://www.emro.who.int/rbm/publications/protocolwho.pdf.
-
2
Djimde AA, Doumbo OK, Traore O, Guindo AB, Kayentao K, Diourte Y, Niare-Doumbo S, Coulibaly D, Kone AK, Cissoko Y, Tekete M, Fofana B, Dicko A, Diallo DA, Wellems TE, Kwiatkowski D, Plowe CV, 2003. Clearance of drug-resistant parasites as a model for protective immunity in Plasmodium falciparum malaria. Am J Trop Med Hyg 69 :558–563.
-
3
Dorsey G, Kamya MR, Ndeezi G, Babirye JN, Phares CR, Olson JE, Katabira ET, Rosenthal PJ, 2000. Predictors of chloroquine treatment failure in children and adults with falciparum malaria in Kampala, Uganda. Am J Trop Med Hyg 62 :686–692.
-
4
Ittarat W, Pickard AL, Rattanasinganchan P, Wilairatana P, Looareesuwan S, Emery K, Low J, Udomsangpetch R, Meshnick SR, 2003. Recrudescence in artesunate-treated patients with falciparum malaria is dependent of parasite burden not on parasite factors. Am J Trop Med Hyg 68 :147–152.
-
5
Talisuna AO, Bloland P, D’Alessandro U, 2004. History, dynamics, and public health importance of malaria parasite resistance. Clin Microbiol Rev 17 :235–254.
-
6
Kamya MR, Dorsey G, Gasasira A, Ndeezi G, Babirye JN, Staedke SG, Rosenthal PJ, 2001. The comparative efficacy of chloroquine and sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in Kampala, Uganda. Trans R Soc Trop Med Hyg 95 :50–55.
-
7
Staedke SG, Kamya MR, Dorsey G, Gasasira A, Ndeezi G, Charlebois ED, Rosenthal PJ, 2001. Amodiaquine, sulfadoxine/pyrimethamine, and combination therapy for treatment of uncomplicated falciparum malaria in Kampala, Uganda: a randomised trial. Lancet 358 :368–374.
-
8
Dorsey G, Njama D, Kamya MR, Cattamanchi A, Kyabayinze D, Staedke SG, Gasasira A, Rosenthal PJ, 2002. Sulfadoxine/pyrimethamine alone or with amodiaquine or artesunate for treatment of uncomplicated malaria: a longitudinal randomised trial. Lancet 360 :2031–2038.
-
9
Gasasira AF, Dorsey G, Nzarubara B, Staedke SG, Nassali A, Rosenthal PJ, Kamya MR, 2003. Comparative efficacy of aminoquinoline-antifolate combinations for the treatment of uncomplicated falciparum malaria in Kampala, Uganda. Am J Trop Med Hyg 68 :127–132.
-
10
Staedke SG, Mpimbaza A, Kamya MR, Nzarubara B, Dorsey G, Rosenthal PJ, 2004. Combination therapies for uncomplicated falciparum malaria in Kampala, Uganda: a randomized clinical trial. Lancet: (in press).
-
11
World Health Organization, 1990. Severe and complicated malaria. Trans R Soc Trop Med Hyg 84 (Suppl 2):1–65.
-
12
World Health Organization, 1996. Assessment of Therapeutic Efficacy of Antimalarial Drugs for Uncomplicated Falciparum Malaria in Areas with Intense Transmission. Geneva: World Health Organization.
-
13
Cattamanchi A, Kyabayinze D, Hubbard A, Rosenthal PJ, Dorsey G, 2003. Distinguishing recrudescence from reinfection in a longitudinal antimalarial drug efficacy study: comparison of results based on genotyping of msp-1, msp-2, and glurp. Am J Trop Med Hyg 68 :133–139.
-
14
Warrell DA, Molyneux ME, Beales PF, 1990. Severe and complicated malaria. Trans R Soc Trop Med Hyg 84 :1–65.
-
15
Zeger SL, Liang KY, 1986. Longitudinal data analysis for discrete and continuous outcomes. Biometrics 42 :121–130.
-
16
Kooperberg C, Clarkson DB, 1997. Hazard regression with interval-censored data. Biometrics 53 :1485–1494.
-
17
Spencer HC, Masaba SC, Kiaraho D, 1982. Sensitivity of Plasmodium falciparum isolates to chloroquine in Kisumu and Malindi, Kenya. Am J Trop Med Hyg 31 :902–906.
-
18
Lewis AN, Dondero TJ Jr, Ponnampalam JT, 1973. Falciparum malaria resistant to chloroquine suppression but sensitive to chloroquine treatment in west Malaysia (letter). Trans R Soc Trop Med Hyg 67 :310–312.
-
19
Bouharoun-Tayoun H, Oeuvray C, Lunel F, Druilhe P, 1995. Mechanisms underlying the monocyte-mediated antibody-dependent killing of Plasmodium falciparum asexual blood stages. J Exp Med 182 :409–418.
-
20
Egan AF, Morris J, Barnish G, Allen S, Greenwood BM, Kaslow DC, Holder AA, Riley EM, 1996. Clinical immunity to Plasmodium falciparum malaria is associated with serum antibodies to the 19-kDa C-terminal fragment of the merozoite surface antigen, PfMSP-1. J Infect Dis 173 :765–769.
-
21
ter Kuile FO, Luxemburger C, Nosten F, Thwai KL, Chongsuphajaisiddhi T, White NJ, 1995. Predictors of mefloquine treatment failure: a prospective study of 1590 patients with uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg 89 :660–664.
-
22
Fontanet AL, Walker AM, 1993. Predictors of treatment failure in multiple drug-resistant falciparum malaria: results from a 42-day follow-up of 224 patients in eastern Thailand. Am J Trop Med Hyg 49 :465–472.
-
23
Olanrewaju WI, Johnson AW, 2001. Chloroquine-resistant Plasmodium falciparum malaria in Ilorin, Nigeria: prevalence and risk factors for treatment failure. Afr J Med Med Sci 30 :165–169.
-
24
Hess FI, Iannuzzi A, Leafasia J, Cowdry D, Nothdurft HD, von Sonnenburg F, Loscher T, Rieckmann KH, 1996. Risk factors of chloroquine resistance in Plasmodium falciparum malaria. Acta Trop 61 :293–306.
-
25
Ehrhardt S, Mockenhaupt FP, Agana-Nsiire P, Mathieu A, Anemana SD, Stark K, Otchwemah RN, Bienzle U, 2002. Efficacy of chloroquine in the treatment of uncomplicated, Plasmodium falciparum malaria in northern Ghana. Ann Trop Med Parasitol 96 :239–247.
-
26
Rogier C, Tall A, Diagne N, Fontenille D, Spiegel A, Trape JF, 1999. Plasmodium falciparum clinical malaria: lessons from longitudinal studies in Senegal. Parassitologia 41 :255–259.
-
27
White NJ, 1997. Assessment of the pharmacodynamic properties of antimalarial drugs in vivo. Antimicrob Agents Chemother 41 :1413–1422.
-
28
White N, 1999. Antimalarial drug resistance and combination chemotherapy. Philos Trans R Soc Lond B Biol Sci 354 :739–749.
-
29
Al-Maktari MT, Bassiouny HK, 2003. Malaria status in Al-Hodeidah Governorate, Republic of Yemen. Part II: Human factors causing the persistence of chloroquine resistant P. falciparum local strain. J Egypt Soc Parasitol 33 :829–839.
-
30
Sokhna CS, Rogier C, Dieye A, Trape JF, 2000. Host factors affecting the delay of reappearance of Plasmodium falciparum after radical treatment among a semi-immune population exposed to intense perennial transmission. Am J Trop Med Hyg 62 :266–270.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 21 | 21 | 7 |
| Full Text Views | 359 | 157 | 3 |
| PDF Downloads | 66 | 23 | 2 |
THE IMPACT OF AGE, TEMPERATURE, AND PARASITE DENSITY ON TREATMENT OUTCOMES FROM ANTIMALARIAL CLINICAL TRIALS IN KAMPALA, UGANDA
GRANT DORSEY
GRANT DORSEY
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Department of Medicine, Makerere University Medical School, Kampala, Uganda; Department of Biostatistics, School of Public Health, University of California, Berkeley, California
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ANNE F. GASASIRA
ANNE F. GASASIRA
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Department of Medicine, Makerere University Medical School, Kampala, Uganda; Department of Biostatistics, School of Public Health, University of California, Berkeley, California
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RHODERICK MACHEKANO
RHODERICK MACHEKANO
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Department of Medicine, Makerere University Medical School, Kampala, Uganda; Department of Biostatistics, School of Public Health, University of California, Berkeley, California
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MOSES R. KAMYA
MOSES R. KAMYA
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Department of Medicine, Makerere University Medical School, Kampala, Uganda; Department of Biostatistics, School of Public Health, University of California, Berkeley, California
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SARAH G. STAEDKE
SARAH G. STAEDKE
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Department of Medicine, Makerere University Medical School, Kampala, Uganda; Department of Biostatistics, School of Public Health, University of California, Berkeley, California
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ALAN HUBBARD
ALAN HUBBARD
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Department of Medicine, Makerere University Medical School, Kampala, Uganda; Department of Biostatistics, School of Public Health, University of California, Berkeley, California
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Antimalarial drug treatment policy in sub-Saharan Africa is generally guided by the results of clinical drug efficacy studies in patients with uncomplicated Plasmodium falciparum malaria. The selection criteria used to enroll these patients often vary and may have a significant impact on treatment outcomes. In Kampala, Uganda, we investigated the impact of age, baseline temperature, and pre-treatment parasite density on estimates of treatment efficacy using a statistical modeling approach in 2,138 patients enrolled in six clinical trials involving seven different treatment regimens. Decreasing age, increasing temperature, and increasing parasite density were all independent predictors of an increased risk of treatment failure across all treatment groups. Compared with an unrestrictive approach to subject selection, enrolling only patients fulfilling selection criteria recommended by the World Health Organization (age < 5 years old, documented fever, and parasite density < 200,000/μL) increased the risk of treatment failure by 25–60% for the different treatment regimens. Caution should be taken when comparing results from drug efficacy studies with different subject selection criteria.
ProCite
RefWorks
Reference Manager
BibTeX
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-
1
World Health Organization, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria. http://www.emro.who.int/rbm/publications/protocolwho.pdf.
-
2
Djimde AA, Doumbo OK, Traore O, Guindo AB, Kayentao K, Diourte Y, Niare-Doumbo S, Coulibaly D, Kone AK, Cissoko Y, Tekete M, Fofana B, Dicko A, Diallo DA, Wellems TE, Kwiatkowski D, Plowe CV, 2003. Clearance of drug-resistant parasites as a model for protective immunity in Plasmodium falciparum malaria. Am J Trop Med Hyg 69 :558–563.
-
3
Dorsey G, Kamya MR, Ndeezi G, Babirye JN, Phares CR, Olson JE, Katabira ET, Rosenthal PJ, 2000. Predictors of chloroquine treatment failure in children and adults with falciparum malaria in Kampala, Uganda. Am J Trop Med Hyg 62 :686–692.
-
4
Ittarat W, Pickard AL, Rattanasinganchan P, Wilairatana P, Looareesuwan S, Emery K, Low J, Udomsangpetch R, Meshnick SR, 2003. Recrudescence in artesunate-treated patients with falciparum malaria is dependent of parasite burden not on parasite factors. Am J Trop Med Hyg 68 :147–152.
-
5
Talisuna AO, Bloland P, D’Alessandro U, 2004. History, dynamics, and public health importance of malaria parasite resistance. Clin Microbiol Rev 17 :235–254.
-
6
Kamya MR, Dorsey G, Gasasira A, Ndeezi G, Babirye JN, Staedke SG, Rosenthal PJ, 2001. The comparative efficacy of chloroquine and sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in Kampala, Uganda. Trans R Soc Trop Med Hyg 95 :50–55.
-
7
Staedke SG, Kamya MR, Dorsey G, Gasasira A, Ndeezi G, Charlebois ED, Rosenthal PJ, 2001. Amodiaquine, sulfadoxine/pyrimethamine, and combination therapy for treatment of uncomplicated falciparum malaria in Kampala, Uganda: a randomised trial. Lancet 358 :368–374.
-
8
Dorsey G, Njama D, Kamya MR, Cattamanchi A, Kyabayinze D, Staedke SG, Gasasira A, Rosenthal PJ, 2002. Sulfadoxine/pyrimethamine alone or with amodiaquine or artesunate for treatment of uncomplicated malaria: a longitudinal randomised trial. Lancet 360 :2031–2038.
-
9
Gasasira AF, Dorsey G, Nzarubara B, Staedke SG, Nassali A, Rosenthal PJ, Kamya MR, 2003. Comparative efficacy of aminoquinoline-antifolate combinations for the treatment of uncomplicated falciparum malaria in Kampala, Uganda. Am J Trop Med Hyg 68 :127–132.
-
10
Staedke SG, Mpimbaza A, Kamya MR, Nzarubara B, Dorsey G, Rosenthal PJ, 2004. Combination therapies for uncomplicated falciparum malaria in Kampala, Uganda: a randomized clinical trial. Lancet: (in press).
-
11
World Health Organization, 1990. Severe and complicated malaria. Trans R Soc Trop Med Hyg 84 (Suppl 2):1–65.
-
12
World Health Organization, 1996. Assessment of Therapeutic Efficacy of Antimalarial Drugs for Uncomplicated Falciparum Malaria in Areas with Intense Transmission. Geneva: World Health Organization.
-
13
Cattamanchi A, Kyabayinze D, Hubbard A, Rosenthal PJ, Dorsey G, 2003. Distinguishing recrudescence from reinfection in a longitudinal antimalarial drug efficacy study: comparison of results based on genotyping of msp-1, msp-2, and glurp. Am J Trop Med Hyg 68 :133–139.
-
14
Warrell DA, Molyneux ME, Beales PF, 1990. Severe and complicated malaria. Trans R Soc Trop Med Hyg 84 :1–65.
-
15
Zeger SL, Liang KY, 1986. Longitudinal data analysis for discrete and continuous outcomes. Biometrics 42 :121–130.
-
16
Kooperberg C, Clarkson DB, 1997. Hazard regression with interval-censored data. Biometrics 53 :1485–1494.
-
17
Spencer HC, Masaba SC, Kiaraho D, 1982. Sensitivity of Plasmodium falciparum isolates to chloroquine in Kisumu and Malindi, Kenya. Am J Trop Med Hyg 31 :902–906.
-
18
Lewis AN, Dondero TJ Jr, Ponnampalam JT, 1973. Falciparum malaria resistant to chloroquine suppression but sensitive to chloroquine treatment in west Malaysia (letter). Trans R Soc Trop Med Hyg 67 :310–312.
-
19
Bouharoun-Tayoun H, Oeuvray C, Lunel F, Druilhe P, 1995. Mechanisms underlying the monocyte-mediated antibody-dependent killing of Plasmodium falciparum asexual blood stages. J Exp Med 182 :409–418.
-
20
Egan AF, Morris J, Barnish G, Allen S, Greenwood BM, Kaslow DC, Holder AA, Riley EM, 1996. Clinical immunity to Plasmodium falciparum malaria is associated with serum antibodies to the 19-kDa C-terminal fragment of the merozoite surface antigen, PfMSP-1. J Infect Dis 173 :765–769.
-
21
ter Kuile FO, Luxemburger C, Nosten F, Thwai KL, Chongsuphajaisiddhi T, White NJ, 1995. Predictors of mefloquine treatment failure: a prospective study of 1590 patients with uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg 89 :660–664.
-
22
Fontanet AL, Walker AM, 1993. Predictors of treatment failure in multiple drug-resistant falciparum malaria: results from a 42-day follow-up of 224 patients in eastern Thailand. Am J Trop Med Hyg 49 :465–472.
-
23
Olanrewaju WI, Johnson AW, 2001. Chloroquine-resistant Plasmodium falciparum malaria in Ilorin, Nigeria: prevalence and risk factors for treatment failure. Afr J Med Med Sci 30 :165–169.
-
24
Hess FI, Iannuzzi A, Leafasia J, Cowdry D, Nothdurft HD, von Sonnenburg F, Loscher T, Rieckmann KH, 1996. Risk factors of chloroquine resistance in Plasmodium falciparum malaria. Acta Trop 61 :293–306.
-
25
Ehrhardt S, Mockenhaupt FP, Agana-Nsiire P, Mathieu A, Anemana SD, Stark K, Otchwemah RN, Bienzle U, 2002. Efficacy of chloroquine in the treatment of uncomplicated, Plasmodium falciparum malaria in northern Ghana. Ann Trop Med Parasitol 96 :239–247.
-
26
Rogier C, Tall A, Diagne N, Fontenille D, Spiegel A, Trape JF, 1999. Plasmodium falciparum clinical malaria: lessons from longitudinal studies in Senegal. Parassitologia 41 :255–259.
-
27
White NJ, 1997. Assessment of the pharmacodynamic properties of antimalarial drugs in vivo. Antimicrob Agents Chemother 41 :1413–1422.
-
28
White N, 1999. Antimalarial drug resistance and combination chemotherapy. Philos Trans R Soc Lond B Biol Sci 354 :739–749.
-
29
Al-Maktari MT, Bassiouny HK, 2003. Malaria status in Al-Hodeidah Governorate, Republic of Yemen. Part II: Human factors causing the persistence of chloroquine resistant P. falciparum local strain. J Egypt Soc Parasitol 33 :829–839.
-
30
Sokhna CS, Rogier C, Dieye A, Trape JF, 2000. Host factors affecting the delay of reappearance of Plasmodium falciparum after radical treatment among a semi-immune population exposed to intense perennial transmission. Am J Trop Med Hyg 62 :266–270.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 21 | 21 | 7 |
| Full Text Views | 359 | 157 | 3 |
| PDF Downloads | 66 | 23 | 2 |