Active Ingredients: Azithromycin
However, only three studies reported day 42 results Pfizer 84227, Sykes, Thriemer. There was a wide variety in the drug combinations, doses of azithromycin and comparator drugs, and regimens used, with 41 treatment arms of the 15 studies involving 12 different antimalarials, and 28 different treatment regimens see Characteristics of included studies or Table 2.
The most common azithromycin combination was 1 g azithromycin with 0. The characteristics of the included studies are given in the Characteristics of included studies table.
All studies except one Pfizer reported excluding subjects with a recent history of intake of an antimalarial, although the period of intake could vary between the last 48 hours to 42 days prior to enrolment.
Risk of bias in included studies The available information did not allow an appropriate evaluation of the quality of the data. The six trial synopses from Pfizer that were publicly available contained limited information on the methods, and did not specify randomization and allocation concealment.
Baseline characteristics were broadly comparable between arms except for the baseline parasite density in the combination arm of a study in India, which was lower than the other arms Table 4, Dunne b. Four trials conducted by Pfizer included an arm with 0.
Results were presented for the 59 participants in the arm for the trial in India Pfizer 74841, but not for this arm in any of the other trials in which nine, 14, and seven participants were enrolled, respectively Pfizer 82576, Pfizer 84227, Pfizer Two studies were reportedly terminated because of a slow rate of recruitment Pfizer 84240, Pfizer 82563 and two arms in one trial were terminated prematurely because of a lack of efficacy Dunne b; results of the enrolled participants in these studies were included in our analyses except for the 0.
A summary of the 'Risk of bias' assessments is presented in Figure 1 and Figure 2. Of the 15 trials included in the assessment of efficacy, the sequence generation and allocation concealment was adequate and judged to be at low risk of bias in three studies, and unknown in the remaining trials.
Only five studies were judged to be at low risk of bias due to adequate blinding. Blinding of laboratory staff was conducted in five open label studies, reducing the bias for the efficacy outcome; however, adverse event reporting will remain at risk of bias in these studies.
We considered almost all trials at risk of selective reporting for one or more of the following reasons: the outcome assessment seemed subjective; there was no baseline data provided by treatment arm; adverse events were not reported by treatment arm; prespecified outcomes were not reported; treatment arms were included that were not randomized; only men were included; interim analyses and subsequent halting of treatment arms; and halting of complete studies before the sample size had been reached.
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