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Table 2 Malaria treatment outcome of pregnant women with malaria episode in Nchelenge, Zambia (2010–2014)

From: Artemisinin-based combination therapy in pregnant women in Zambia: efficacy, safety and risk of recurrent malaria

  AL (N = 300) MQAS (N = 300) DHAPQ (N = 300)
Efficacy outcomes, n (%)
Early treatment failurea 0 0 1
Late clinical and parasitological treatment failurea 126 60 36
 Recrudescence 12 5 2
 New infection 114 55 34
Adequate clinical and parasitological responsea 132 175 199
Cannot be determined 42 65 64
 Did not meet inclusion/exclusion criteria/missing 8 17 8
 Treatment violations 1 0 1
 No PCR sample 0 3 4
 LTFU/died/withdrawn 33 45 51
Treatment failure rate % (95% CI)
PP-analysis: PCR-unadjusted 48.4 (42.4–54.5) 23.9 (19.0–29.8) 16.3 (12.1–21.4)
PP-analysis: PCR-adjusted 4.7 (2.7–8.0) 1.3 (0.4–3.7) 0.8 (0.2–3.0)
ITT-analysis: PCR-unadjusted 47.6 (41.7–53.5) 25.1 (20.2–30.8) 16.5 (12.4–21.6)
ITT-analysis: PCR-adjusted 4.9 (2.9–8.2) 2.0 (0.9–4.6) 1.2 (0.4–3.5)
Placental malaria N = 235 N = 228 N = 227
 Acute infection, n (%) 3 (1.3) 2 (0.9) 0 (0.0)
 Chronic infection, n (%) 75 (31.9) 70 (30.7) 67 (29.5)
 Past infection, n (%) 148 (63.0) 139 (61.0) 146 (64.3)
 No infection, n (%) 9 (3.8) 17 (7.5) 14 (6.2)
  1. LTFU Lost to follow-up; PP per-protocol; ITT intention-to-treat
  2. aEarly Treatment Failure (ETF) defined as one of the following: (i) development of danger signs or severe malaria or worsening of clinical conditions on day 0, day 1, day 2 or day 3, in the presence of parasitaemia, (ii) parasitaemia on day 3 ≥count on day 0, (iii) parasitaemia on day 3 and fever (axillary temperature ≥37.5 °C). Late clinical failure (LCF) defined as (i) development of danger signs or severe malaria or worsening of clinical conditions on any day after day 3 in the presence of parasitaemia, without previously meeting any of the criteria of Early Treatment Failure or (i) presence of parasitaemia and fever on any day after day 3, without having previously meet the criteria of ETF. Late parasitological failure (LCF) defined as presence of parasitaemia on any day from day 4 onwards and axillary temperature <37.5 °C, without previously meeting any of the criteria of ETF or LCF. Adequate clinical and parasitological response (ACPR) defined as absence of parasitaemia at the end of the follow up period (day 63), irrespective of axillary temperature without previously meeting any of the criteria of early and late treatment failure. In the PCR-adjusted estimates, patients with late asexual parasite reappearance (with or without fever) are considered ACPR if the PCR analysis shows a new infection rather than a recrudescence. Placental malaria classified as: acute infection (parasite present, malaria pigment absent); chronic infection (parasites and malaria pigment present); past infection (no parasite but pigment present); no infection (both parasites and malaria pigment absent)