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Artemisinin-naphthoquine combination (ARCO) therapy for uncomplicated falciparum malaria in adults of Papua New Guinea: a preliminary report on safety and efficacy.

Hombhanje FW, Linge D, Saweri A, Kuanch C, Jones R, Toraso S, Geita J, Masta A, Kevau I, Hiawalyer G, Sapuri M - Malar. J. (2009)

Bottom Line: A study was undertaken to assess the safety, efficacy and tolerability of ANQ combination in areas of multi-drug resistance to generate preliminary baseline data in adult population of Papua New Guinea.The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events.Both regimens were well tolerated with no serious adverse events.

View Article: PubMed Central - HTML - PubMed

Affiliation: Faculty of Health Sciences, Divine Word University, Madang Province, Papua New Guinea. fhombhanje@dwu.ac.pg

ABSTRACT

Background: The use of anti-malarial drug combinations with artemisinin or with one of its derivatives is now widely recommended to overcome drug resistance in falciparum as well as vivax malaria. The fixed oral dose artemisinin-naphthoquine combination (ANQ, ARCO) is a newer artemisinin-based combination (ACT) therapy undergoing clinical assessment. A study was undertaken to assess the safety, efficacy and tolerability of ANQ combination in areas of multi-drug resistance to generate preliminary baseline data in adult population of Papua New Guinea.

Methods: The clinical assessment was an open-labeled, two-arm, randomized study comparing ANQ combination as a single dose regimen and three days regimen (10 mg/kg/day) of chloroquine plus single dose sulphadoxine-pyrimethamine (CQ+SP) for the treatment of uncomplicated falciparum malaria with 28 days follow-up in an adult population. The primary outcome measures for efficacy were day 1, 2, 3 7, 14 and 28-day cure rates. Secondary outcomes included parasite clearance time, fever clearance time, and gametocyte carriage. The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events.

Results: Between June 2005 and July 2006, 130 patients with confirmed uncomplicated P. falciparum were randomly assigned to receive ANQ and CQ+SP, only 100 patients (51 in ANQ group and 49 in CQ+SP group) were evaluated for clinical and parasitological outcomes. All the patients treated with ANQ and CQ+SP showed adequate clinical and parasitological response with 28 days follow-up. The cure rate for ANQ on day 1, 2, 3, 7, 14, and 28 was 47%, 86%, 92%, 94%, 94% and 94%, respectively. Recrudescence account for 6%; all were cleared on day 21. For CQ+SP treated group the cure rates were 24%, 67%, 82%, 82%, 84% and 88%, respectively. Recrudescence accounted for 10%; all were cleared on day 28 except for one patient. Both regimens were well tolerated with no serious adverse events. The proportion of gametocyte carriers was higher in CQ+SP treated group than ANQ treatment (41% versus 12%; p < 0.05).

Conclusion: While these data are not themselves sufficient, it strongly suggests that the ANQ combination as a single dose administration is safe and effective for the treatment of uncomplicated P. falciparum malaria in the adult population of Papua New Guinea and deserves further clinical evaluation.

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The response of the patients' axillary body temperatures (°C = degree Celsius) after the start of the two treatments (ANQ versus CQ+SP).
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Figure 2: The response of the patients' axillary body temperatures (°C = degree Celsius) after the start of the two treatments (ANQ versus CQ+SP).

Mentions: Only 76 patients of 100 patients were evaluated for FCT; remaining 24 patients had a temperature <37.5°C on admission. However, within 24 hrs, 50% of the afebrile patients in each group developed fever (≥37.5°C). The general profile of temperature resolution in both treatment groups is shown in Figure 2. The mean FCTA was 13.6 ± 9.6 hr in ANQ group versus 17.2 ± 9.9 hr in CQ+SP (p > 0.05). The mean FCTB was 19.8 ± 12.7 hr in ANQ group versus 31.7 ± 21.5 hr in CQ+SP group (p > 0.05).


Artemisinin-naphthoquine combination (ARCO) therapy for uncomplicated falciparum malaria in adults of Papua New Guinea: a preliminary report on safety and efficacy.

Hombhanje FW, Linge D, Saweri A, Kuanch C, Jones R, Toraso S, Geita J, Masta A, Kevau I, Hiawalyer G, Sapuri M - Malar. J. (2009)

The response of the patients' axillary body temperatures (°C = degree Celsius) after the start of the two treatments (ANQ versus CQ+SP).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2734862&req=5

Figure 2: The response of the patients' axillary body temperatures (°C = degree Celsius) after the start of the two treatments (ANQ versus CQ+SP).
Mentions: Only 76 patients of 100 patients were evaluated for FCT; remaining 24 patients had a temperature <37.5°C on admission. However, within 24 hrs, 50% of the afebrile patients in each group developed fever (≥37.5°C). The general profile of temperature resolution in both treatment groups is shown in Figure 2. The mean FCTA was 13.6 ± 9.6 hr in ANQ group versus 17.2 ± 9.9 hr in CQ+SP (p > 0.05). The mean FCTB was 19.8 ± 12.7 hr in ANQ group versus 31.7 ± 21.5 hr in CQ+SP group (p > 0.05).

Bottom Line: A study was undertaken to assess the safety, efficacy and tolerability of ANQ combination in areas of multi-drug resistance to generate preliminary baseline data in adult population of Papua New Guinea.The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events.Both regimens were well tolerated with no serious adverse events.

View Article: PubMed Central - HTML - PubMed

Affiliation: Faculty of Health Sciences, Divine Word University, Madang Province, Papua New Guinea. fhombhanje@dwu.ac.pg

ABSTRACT

Background: The use of anti-malarial drug combinations with artemisinin or with one of its derivatives is now widely recommended to overcome drug resistance in falciparum as well as vivax malaria. The fixed oral dose artemisinin-naphthoquine combination (ANQ, ARCO) is a newer artemisinin-based combination (ACT) therapy undergoing clinical assessment. A study was undertaken to assess the safety, efficacy and tolerability of ANQ combination in areas of multi-drug resistance to generate preliminary baseline data in adult population of Papua New Guinea.

Methods: The clinical assessment was an open-labeled, two-arm, randomized study comparing ANQ combination as a single dose regimen and three days regimen (10 mg/kg/day) of chloroquine plus single dose sulphadoxine-pyrimethamine (CQ+SP) for the treatment of uncomplicated falciparum malaria with 28 days follow-up in an adult population. The primary outcome measures for efficacy were day 1, 2, 3 7, 14 and 28-day cure rates. Secondary outcomes included parasite clearance time, fever clearance time, and gametocyte carriage. The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events.

Results: Between June 2005 and July 2006, 130 patients with confirmed uncomplicated P. falciparum were randomly assigned to receive ANQ and CQ+SP, only 100 patients (51 in ANQ group and 49 in CQ+SP group) were evaluated for clinical and parasitological outcomes. All the patients treated with ANQ and CQ+SP showed adequate clinical and parasitological response with 28 days follow-up. The cure rate for ANQ on day 1, 2, 3, 7, 14, and 28 was 47%, 86%, 92%, 94%, 94% and 94%, respectively. Recrudescence account for 6%; all were cleared on day 21. For CQ+SP treated group the cure rates were 24%, 67%, 82%, 82%, 84% and 88%, respectively. Recrudescence accounted for 10%; all were cleared on day 28 except for one patient. Both regimens were well tolerated with no serious adverse events. The proportion of gametocyte carriers was higher in CQ+SP treated group than ANQ treatment (41% versus 12%; p < 0.05).

Conclusion: While these data are not themselves sufficient, it strongly suggests that the ANQ combination as a single dose administration is safe and effective for the treatment of uncomplicated P. falciparum malaria in the adult population of Papua New Guinea and deserves further clinical evaluation.

Show MeSH
Related in: MedlinePlus