Committee Recommendations in Order of Significance

Recommendation: In view of the importance of the unpublished analyses by the SWG in showing a net benefit for IPTI-SP, and whereas the committee had no information about how the SWG or the individual study teams ensured quality control of the individual study data and hence the uniformly defined outcomes, the committee recommends that the SWG obtain an independent technical audit of the accuracy of the study-level data and analyses included in the pooled analysis. If this audit confirms the results presented, the committee would support the notion that IPTi-SP is ready to move to a new level. The committee’s confidence in the efficacy of IPTi-SP in preventing cases of clinical malaria is sufficient to encourage larger-scale pilot implementations and evaluations in areas where the incidence of malaria in infants is high (often areas of perennial, high- and moderate-level transmission areas) to assess the impact of the intervention under real-life conditions. The provision of stronger evidence on these issues would be invaluable; the committee, however, recognizes that trying to estimate these parameters may involve an ethical challenge. If the evidence of IPTi-SP in preventing clinical malaria is deemed sufficient to propose instituting pilot implementations, there may not be sufficient equipoise to justify large controlled trials of IPTi-SP to evaluate its ability to prevent anemia, hospitalizations with malaria, or all-cause hospitalizations. One possible solution might be to nest case-control studies within large-scale, population-based pilot implementations of IPTi-SP. Nested studies of various designs may allow assessment of the effectiveness of IPTi in preventing malaria hospitalizations, anemia, and infant deaths.

Recommendation: If large-scale implementation is to be pursued, the committee recommends that the first IPTi-SP programs should be used where the infant population is at high risk for malaria morbidity because of perennial, high- and moderate-intensity transmission. Support should be continued for current efforts to identify more precise parameters, such as transmission intensity, seasonality of transmission, DPT3 coverage, and severity of clinical disease for locations in which IPTi-SP is to be implemented. Additionally, if large-scale implementations proceed or wherever large pilot projects are carried out, the committee urges that attempts be made to evaluate the impact of IPTi-SP on mortality in infant and young children

Recommendation: The committee recommends that if programmatic implementation of IPTi-SP were to ensue, public health authorities should monitor evidence of possible increases or decreases of SP resistance in the areas or regions of implementation.

Recommendation: Because of the issues discussed in this document, plans for monitoring and evaluation should accompany the programmatic implementation of IPTi-SP. Indicators would include the burden of malaria in infancy, which is likely to change in response to ongoing and new interventions, SP resistance, side effects, and impact on EPI coverage. Post-implementation monitoring of IPTi-SP would benefit from a baseline assessment followed by regular measurements of the burden of malaria in infancy. This could be accomplished through surveillance at sentinel sites, including hospitals and primary-care centers; in different transmission settings; and in other intercountry networks with capacity for data collection. Once the policy is well established and large-scale implementation is shown to be effective, notable changes may be detected in the age distribution of the pediatric malaria burden that may warrant modification of the policy. For example, if the frequency of infant malaria begins to increase, programmatic shortcomings and the emergence of drug resistance would require investigation. If IPTi, in conjunction with other measures, is highly effective and infant malaria is dramatically reduced or eliminated, the program may be modified to target the appropriate vulnerable age groups, possibly to include older children.

Recommendation: If larger-scale implementation of IPTi-SP in a given country were to ensue, it should be accompanied by the collection of evidence under varying conditions that are likely to affect the cost-effectiveness of the intervention, including the extent to which there is excess capacity under EPI (e.g., staff time, equipment, and vehicle use) to implement IPTi-SP; malaria transmission intensities; the case-fatality rates; the unit prices of IPTi drugs; and the program start-up costs.

Recommendation: Post-implementation monitoring should include pharmacovigilance with longer-term follow-up for children (e.g., 24 months) to detect adverse reactions that may arise when recipients of IPTi-SP in infancy subsequently receive cotrimoxazole or other sulfa drugs.

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