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. 2016 Apr 14;2016(4):CD006419. doi: 10.1002/14651858.CD006419.pub4

Suputtamongkol 2011 THA.

Methods Trial design: randomized, non‐blinded study.
Participants: adult participants with chronic strongyloidiasis.
Length of follow‐up: participants were followed up 2 weeks after treatment initiation, then 1 month, 3 months, 6 months, 9 months, and 1 year post‐treatment.
Monitoring and diagnostics: infection with Strongyloides stercoralis was ascertained using the direct smear, formol‐ether concentration method, and modified Koga agar plate culture method.
Participants Number of participants: 90 adult participants with chronic Strongyloides infection were recruited. There were 10 participants with HIV co‐infections, with 3 HIV‐positive participants randomized to albendazole, 2 HIV‐positive participants randomized to single dose ivermectin, and 5 HIV‐positive participants randomized to double dose ivermectin.
Inclusion criteria: adult participants with characteristic rhabditiform larvae of S. stercoralis present on faecal microscopy.
Exclusion criteria: history of allergic reaction to either study medication, treatment within the month prior to the trial with any drug known to have anti‐Strongyloides activity, pregnancy, or lactation, and any suggestion of disseminated strongyloidiasis.
Interventions Intervention: Group 1: ivermectin delivered as a single dose of 200 µg/kg; Intervention. Group 2: 2 doses of ivermectin (200 µg/kg) delivered 2 weeks apart. For the purpose of this analysis we considered both groups that received ivermectin together.
Control: participants received 7 days of albendazole (800 mg per day).
Outcomes Outcomes included in this review: incidence of adverse events defined as "symptoms or signs that developed after the study drug administration and had not been reported prior to the administration of the first dose of the antihelmintic."
Other trial outcomes: treatment cure (defined as clinical improvement (if symptomatic before treatment) and the absence of rhabditiform larvae in the stool at day 14 of treatment and throughout the follow‐up period) and treatment failure (defined as the presence of larvae two weeks after initiation of treatment or the reappearance of larvae during follow‐up).
Notes Location: Siriraj Hospital, Thailand
Participant helminth status: ascertained
Participant ART status: it was unspecified if any individuals were receiving ART treatment at the start or during the trial.
Author contact: we requested additional data regarding the incidence of adverse events in the HIV‐positive participants specifically from the trial authors, who provided this information.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Computer generated, simple, random allocation sequences were prepared for 3 study groups by the investigator team."
Allocation concealment (selection bias) Low risk "These were sealed in an opaque envelope and numbered. The investigator assigned study participants to their respective treatment group after opening the sealed envelope."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk "prospective open‐label, randomised, controlled study".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk It is unclear whether or not the assessor was blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There was 10% loss to follow‐up; "Ten patients were excluded from analysis because they did not receive or complete the study treatment (3 in albendazole group, 2 in ivermectin‐II group), or they were lost to follow‐up immediately after treatment (3 in albendazole group, 1 each in ivermectin‐I and ivermectin‐II respectively)."