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Varying efficacy of artesunate+amodiaquine and artesunate+sulphadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in the Democratic Republic of Congo: a report of two in-vivo studies.

Bonnet M, Broek Iv, van Herp M, Urrutia PP, van Overmeir C, Kyomuhendo J, Ndosimao CN, Ashley E, Guthmann JP - Malar. J. (2009)

Bottom Line: The results of two in vivo efficacy studies, which tested AQ and sulphadoxine-pyrimethamine (SP) monotherapies and AS+SP and AS+AQ combinations in Boende (Equatorial province), and AS+SP, AS+AQ and SP in Kabalo (Katanga province), between 2003 and 2004 are presented.The finding of varying efficacy of the same combinations at two sites in one country highlights one difficulty of implementing a uniform national treatment policy in a large country.The poor efficacy of AS+AQ in Boende should alert the national programme to foci of resistance and emphasizes the need for systems for the prospective monitoring of treatment efficacy at sentinel sites in the country.

View Article: PubMed Central - HTML - PubMed

Affiliation: Epicentre, Geneva 21, Switzerland. maryline.bonnet@geneva.msf.org

ABSTRACT

Background: Very few data on anti-malarial efficacy are available from the Democratic Republic of Congo (DRC). DRC changed its anti-malarial treatment policy to amodiaquine (AQ) and artesunate (AS) in 2005.

Methods: The results of two in vivo efficacy studies, which tested AQ and sulphadoxine-pyrimethamine (SP) monotherapies and AS+SP and AS+AQ combinations in Boende (Equatorial province), and AS+SP, AS+AQ and SP in Kabalo (Katanga province), between 2003 and 2004 are presented. The methodology followed the WHO 2003 protocol for assessing the efficacy of anti-malarials in areas of high transmission.

Results: Out of 394 included patients in Boende, the failure rates on day 28 after PCR-genotyping adjustment of AS+SP and AS+AQ were estimated as 24.6% [95% CI: 16.6-35.5] and 15.1% [95% CI: 8.6-25.7], respectively. For the monotherapies, failure rates were 35.9% [95% CI: 27.0-46.7] for SP and 18.3% [95% CI: 11.6-28.1] for AQ. Out of 207 patients enrolled in Kabalo, the failure rate on day 28 after PCR-genotyping adjustment was 0 [1-sided 95% CI: 5.8] for AS+SP and AS+AQ [1-sided 95% CI: 6.2]. It was 19.6% [95% CI: 11.4-32.7] for SP monotherapy.

Conclusion: The finding of varying efficacy of the same combinations at two sites in one country highlights one difficulty of implementing a uniform national treatment policy in a large country. The poor efficacy of AS+AQ in Boende should alert the national programme to foci of resistance and emphasizes the need for systems for the prospective monitoring of treatment efficacy at sentinel sites in the country.

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Details of inclusions and follow-up in thestudies in Boende and Kabalo.
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Figure 2: Details of inclusions and follow-up in thestudies in Boende and Kabalo.

Mentions: A total of 1,005 children were screened between September 2003 and February 2004, of whom 394 (39.2%) were enrolled (Figure 2). Three patients (0.8%) were lost to follow up. Baseline characteristics are presented in Table 1. Trends in fever, parasitaemia and haemoglobin over time are presented in Table 2. More than one quarter of patients treated with AS+SP or AS+AQ were parasitaemic on day 7. Of 68 children still parasitaemic on day 7, 3 had a fever and were classified as failures. The day 28 unadjusted failure rates were 55.5% [95% confidence interval CI: 46.0–65.4] for SP, 25.7% [95% CI: 18.3–35.4] for AQ, 52.2% [95% CI: 42.3–62.9] for AS+SP and 41.0% [95% CI: 31.3–52.3] for AS+AQ. PCR genotyping results are shown in Table 3. The end-point classifications after PCR adjustment are shown in Table 4. For the monotherapies, PCR adjusted failure rates were 35.9% [95% CI: 27.0–46.7] for SP and 18.3% [95% CI: 11.6–28.1] for AQ. Failure rates on day 28 after PCR-genotyping adjustment of AS+SP and AS+AQ were estimated as 24.6% [95%CI 16.6–35.5] and 15.1% [95%CI: 8.6–25.7], respectively. There were 2 (2.6%) ETFs in the SP arm and none in the other arms. Approximately half of all patients treated with SP, AQ or AS+SP required re-treatment by day 28. No child developed severe malaria after enrolment and there were no deaths. Three children were withdrawn from the study in the first week due to serious concomitant illness- pneumonia, dysentery and suspected meningitis.


Varying efficacy of artesunate+amodiaquine and artesunate+sulphadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in the Democratic Republic of Congo: a report of two in-vivo studies.

Bonnet M, Broek Iv, van Herp M, Urrutia PP, van Overmeir C, Kyomuhendo J, Ndosimao CN, Ashley E, Guthmann JP - Malar. J. (2009)

Details of inclusions and follow-up in thestudies in Boende and Kabalo.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2734861&req=5

Figure 2: Details of inclusions and follow-up in thestudies in Boende and Kabalo.
Mentions: A total of 1,005 children were screened between September 2003 and February 2004, of whom 394 (39.2%) were enrolled (Figure 2). Three patients (0.8%) were lost to follow up. Baseline characteristics are presented in Table 1. Trends in fever, parasitaemia and haemoglobin over time are presented in Table 2. More than one quarter of patients treated with AS+SP or AS+AQ were parasitaemic on day 7. Of 68 children still parasitaemic on day 7, 3 had a fever and were classified as failures. The day 28 unadjusted failure rates were 55.5% [95% confidence interval CI: 46.0–65.4] for SP, 25.7% [95% CI: 18.3–35.4] for AQ, 52.2% [95% CI: 42.3–62.9] for AS+SP and 41.0% [95% CI: 31.3–52.3] for AS+AQ. PCR genotyping results are shown in Table 3. The end-point classifications after PCR adjustment are shown in Table 4. For the monotherapies, PCR adjusted failure rates were 35.9% [95% CI: 27.0–46.7] for SP and 18.3% [95% CI: 11.6–28.1] for AQ. Failure rates on day 28 after PCR-genotyping adjustment of AS+SP and AS+AQ were estimated as 24.6% [95%CI 16.6–35.5] and 15.1% [95%CI: 8.6–25.7], respectively. There were 2 (2.6%) ETFs in the SP arm and none in the other arms. Approximately half of all patients treated with SP, AQ or AS+SP required re-treatment by day 28. No child developed severe malaria after enrolment and there were no deaths. Three children were withdrawn from the study in the first week due to serious concomitant illness- pneumonia, dysentery and suspected meningitis.

Bottom Line: The results of two in vivo efficacy studies, which tested AQ and sulphadoxine-pyrimethamine (SP) monotherapies and AS+SP and AS+AQ combinations in Boende (Equatorial province), and AS+SP, AS+AQ and SP in Kabalo (Katanga province), between 2003 and 2004 are presented.The finding of varying efficacy of the same combinations at two sites in one country highlights one difficulty of implementing a uniform national treatment policy in a large country.The poor efficacy of AS+AQ in Boende should alert the national programme to foci of resistance and emphasizes the need for systems for the prospective monitoring of treatment efficacy at sentinel sites in the country.

View Article: PubMed Central - HTML - PubMed

Affiliation: Epicentre, Geneva 21, Switzerland. maryline.bonnet@geneva.msf.org

ABSTRACT

Background: Very few data on anti-malarial efficacy are available from the Democratic Republic of Congo (DRC). DRC changed its anti-malarial treatment policy to amodiaquine (AQ) and artesunate (AS) in 2005.

Methods: The results of two in vivo efficacy studies, which tested AQ and sulphadoxine-pyrimethamine (SP) monotherapies and AS+SP and AS+AQ combinations in Boende (Equatorial province), and AS+SP, AS+AQ and SP in Kabalo (Katanga province), between 2003 and 2004 are presented. The methodology followed the WHO 2003 protocol for assessing the efficacy of anti-malarials in areas of high transmission.

Results: Out of 394 included patients in Boende, the failure rates on day 28 after PCR-genotyping adjustment of AS+SP and AS+AQ were estimated as 24.6% [95% CI: 16.6-35.5] and 15.1% [95% CI: 8.6-25.7], respectively. For the monotherapies, failure rates were 35.9% [95% CI: 27.0-46.7] for SP and 18.3% [95% CI: 11.6-28.1] for AQ. Out of 207 patients enrolled in Kabalo, the failure rate on day 28 after PCR-genotyping adjustment was 0 [1-sided 95% CI: 5.8] for AS+SP and AS+AQ [1-sided 95% CI: 6.2]. It was 19.6% [95% CI: 11.4-32.7] for SP monotherapy.

Conclusion: The finding of varying efficacy of the same combinations at two sites in one country highlights one difficulty of implementing a uniform national treatment policy in a large country. The poor efficacy of AS+AQ in Boende should alert the national programme to foci of resistance and emphasizes the need for systems for the prospective monitoring of treatment efficacy at sentinel sites in the country.

Show MeSH
Related in: MedlinePlus