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Table 3 Failure rates overall and per site on day 28 and 42 using the ITT and mITT populations

From: Low risk of recurrence following artesunate–Sulphadoxine–pyrimethamine plus primaquine for uncomplicated Plasmodium falciparum and Plasmodium vivax infections in the Republic of the Sudan

 

P. falciparum (PCR corrected)

P. vivax

Pf-noPQ

Pf-PQ1

p value

Hazards ratio

Pv-noPQ

Pv-PQ14

p value

Hazards ratio

ITT

 D28

  Overall (95% CI)

2.35 (0.59–9.08)

0.86 (0.12–5.96)

0.419

0.385 (0.035–4.241)

9.93 (3.31–27.76)

0.00

0.046

  New Halfa (95% CI)

2.90 (0.73–11.10)

1.03 (0.15–7.09)

0.406

0.374 (0.034–4.129)

20.0 (3.08–79.62)

0.00

0.157

_

  Gezira Slanj (95% CI)

0.00

0.00

1.000

8.17 (2.11–28.92)

0.00

0.120

_

  p valueb

0.493

0.658

0.487

1.000

 D42

  Overall (95% CI)

3.75 (1.22–11.22)

0.86 (0.12–5.96)

0.189

0.247 (0.026–2.378)

13.39 (5.24–31.91)

5.26 (1.34–19.44)

0.212

0.358 (0.066–1.956)

  New Halfa (95% CI

4.66 (1.52–13.85)

1.03 (0.15–7.09)

0.176

0.238 (0.025–2.293)

20.0 (3.08–79.62)

0.00

0.157

  Gezira Slanj (95% CI)

0.00

0.00

1.000

12.35 (4.15–33.59)

7.14 (1.84–25.65)

0.480

0.535 (0.089–3.200)

  p valueb

0.389

0.658

0.392

0.684

mITTa

 D28

  Overall (95% CI)

2.00 (0.28–13.36)

0.00

0.282

0.00

0.00

1.000

  New Halfa (95% CI)

2.86 (0.41–18.60)

0.00

0.237

0.00

0.00

1.000

  Gezira Slanj (95% CI)

0.00

0.00

1.000

0.00

0.00

1.000

  p valueb

0.513

1.000

1.000

1.000

 D42

  Overall (95% CI)

4.28 (1.08–16.10)

0.00

0.117

0.00

6.90 (1.77–24.86)

0.247

  New Halfa (95% CI)

6.21 (1.58–22.73)

0.00

0.083

0.00

0.00

1.000

  Gezira Slanj (95% CI)

0.00

0.00

1.000

0.00

10.00 (2.60–34.40)

0.186

  p valueb

0.340

1.000

1.00

0.334

0.334

  1. Significant values are in italics (p < 0.05)
  2. amITT population excluded 132 (42.7%) with incomplete or suboptimal dosing of study drugs
  3. bThis p value refers to site specific differences and does not consider overall results